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CNS Role Specialty Practicum I: Scholarly Project Paper
Translating Evidence into Practice: Therapeutic Hypothermia in Adult Post Cardiac Arrest
Patients
Roshan Jan Muhammad
The Johns Hopkins University School of Nursing
“On my honor, I pledge that I have neither given or nor received any unauthorized assistance on
this assignment”. RJM
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Abstract
Despite successful cardiopulmonary resuscitation (CPR), the victims of cardiac arrest
(CA) have grave prognosis. The most common cause of mortality among post CA patients is
anoxic brain injury that accounts for two third deaths in these victims (Stub et al., 2011). This is a
consequence of pathological events at cellular level secondary to disrupted calcium homeostasis,
free radical formation, and activation of cell-death signaling pathways (Neumar et al., 2008).
Therapeutic hypothermia (TH) is recommended as a part of post CA care by International Liaison
Committee of Resuscitation (ILCOR) to halt the adverse effects of ischemia on brain; and it is
associated with reduced mortality and improved neurological outcome in post CA patients (Nolan
et al. (2010)). The purpose of this project was to transform post CA care at the Medical/Surgical
Intensive Care Unit (ICU) of the Aga Khan University Hospital (AKUH) by introducing evidence
based TH intervention. This pilot project was guided by Complex Adaptive Systems Theory of
change. It encompassed need assessment of the institution; multidisciplinary teambuilding;
evidenced based protocol development though systematic review; establishment of process
monitoring and outcome analysis; resource mobilization; clinical capacity building of the nursing
staff; implementation; and execution of measures to ensure sustainability. The success of this
pilot project, which is planned for 9 months, would open the avenue of replication to other units
like Emergency, Coronary Care Unit and Cardiothoracic Care Unit.
Key words: Therapeutic hypothermia (TH),Cardiac arrest (CA), return of spontaneous
circulation (ROSC), shockable rhythm (ventricular fibrillation or pulseless ventricular
tachycardia), non-shockable rhythm (Asystole or pulseless electrical activity), neurological
outcome, mortality, in-hospital, out of hospital cardiac arrest (OHCA)
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Introduction
CA and related mortality and morbidity are commonly encountered phenomena in a
hospital setting. Despite aggressive measures, the outcome post cardiac arrest is still poor, with
only 7% to 30% of the patients being discharged from hospital with good neurological outcome
(Granja et al., 2011). According to Neumer et al. (2008), CA causes global ischemia, nonetheless,
brain is most vulnerable to the adversity of poor perfusion. Neurological damage starts within
four to six minutes of CA, if CPR is not initiated. Nevertheless, effective CPR only partially
restores perfusion to the vital organs (Cour et al., 2011). While ischemia during CA is damaging
to the brain, evidences also suggest that reperfusion post return of spontaneous circulation
(ROSC) compliments initial hypoxic insult and perpetuates mitochondrial dysfunction and
cellular death (Cour et al., 2011). Consequently, those who survive from CA suffer serious
debilitating neurological complications or die due to post cardiac arrest syndrome (Stub et al.,
2011). The risk of poor neurological outcome increases with each degree increment in body
temperature above 37C post ROSC (Nolan et al., 2010).
Mild TH that ranges from 32C to 34C, is known to improve neurological outcome of
post CA patients through various neuro-protective effects (Nolan et al., 2010). During the project,
I reviewed and synthesized evidences on the role of TH in post CA patients; converged evidences
to develop clinical protocol; and initiated pilot project to assess the feasibility of implementing
TH for adult post CA patients in the ICU of the AKUH.
Assessment of Organizational Need
For this project the facility of AKUH was selected, which is a tertiary care teaching
hospital in Karachi, Pakistan. AKUH is also one of the training centers of the American Heart
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Association (AHA), which is determined to improve the process and outcome of CA in their
facility. According to the CPR committee of the AKUH, total 898 adult patients sustained CA out
of 1,37,355 discharges during the period of 2010 to September 2012 at AKUH, with cumulative
incidence of 6.53 patients per 1000 discharges. Of 898 patients, only 139 patients survived till the
time of the discharge, thus, the overall unadjusted survival to discharge rate is 15.47% in this
cohort. Unfortunately, there is no data available on national incidence of CA and related outcome
in Pakistan. Therefore, the survival rate of CA at AKUH is compared with the findings reported
by the National Registry of Cardiopulmonary Resuscitation of USA. According to the National
Registry, the overall rate of survival to discharge was 22.3% and the rate of survival with good
neurological outcome was 72% in CA patients during 2009 (Girotra et al., 2012). At the time of
assessment, there was no mechanism at AKUH to monitor and follow the cerebral performance of
post CA survivors at the time of discharge, thus, the quantum of problem could not be completely
gauged. However, comparison of the survival rate revealed that there was an opportunity for
AKUH to improve further in this area of health concern.
To improve the survival outcome and salvage the neurological state of post CA victims
require multi-facet interventions. It include high quality CPR; advanced cardiopulmonary
resuscitation (ACLS); optimal support to the vital organs post ROSC; and intervention like
therapeutic hypothermia to minimize the neurological sequel (Stub et al., 2011). AKUH has well
established policies, procedure and mechanisms to address aforesaid critical needs of post CA
patients. All medical staff and paramedics are trained to perform CPR; ACLS trained code team
members respond to the code call, routine mock code drills are performed as a quality
improvement activities and oversight mechanism is established in form of CPR committee.
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However, they have not yet adopted the practice of TH. Nonetheless, leadership of the CPR
committee and clinical leadership of the ICU were motivated to embark on this initiative.
Literature Review
TH is a tri-phasic intervention which typically include; induction, maintenance and
rewarming phase (Stub et al., 2011). According to Beddingfield et al., (2012), TH prevents
astroglial proliferation and blocks the cascade of pro inflammatory mediators. Also, it mitigates
brain damage by reducing cerebral metabolic requirement; decreasing cerebral edema; inhibiting
reperfusion injury; and limiting apoptosis. Despite all goods, hypothermia intervention is not free
of complication. Shivering, electrolyte imbalance, hyperglycemia, hypotension, bradycardia, QT
prolongation, arrhythmias, bleeding and increased risk of infection are few infrequent and
nonfatal side effects of TH (Nolan et al., 2010).
First time, neuro-protective effects of TH were acknowledged in 2002, when two
independent randomized controlled trials (RCTs) by Bernard et al. (2002) and HACA study group
(2002) revealed significant positive outcomes of TH in patients with out of hospital cardiac arrest
(OHCA) with an initial rhythm of ventricular fibrillation (VF). In lieu of these findings, in 2003,
ILCOR recommended the use of TH in the treatment of adult post CA patients (Nolan et al.,
2003). However, the recommendation was restricted to only OHCA victims whose initial rhythm
at the time of CA was shockable. Thereafter, in 2010, scientific statement released by American
Heart Association endorsed the same recommendation based on the findings of subsequent
studies, also expanded the scope of treatment to patients who sustained CA in-hospital and
patients who had initial non-shockable rhythm (Nolan et al., 2010).
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I conducted systematic review on “TH and its impact on neurological and survival
outcomes in adult post cardiac arrest patients” to synthesize evidences and consolidate it into
protocol form to guide practice. Search engines like PubMed, EMBASE, CINAHL and Cochrane
were explored for the period of 2007-2012 using database specific MeSH terms. The search was
truncated to RCT, quasi-experimental studies and non-experimental quantitative studies
conducted on patients over the age of 18years. After eliminating duplication and the review of
abstracts, seventeen articles were found relevant. Of which 10 articles were considered during
synthesis process excluding the low quality (III C) evidences. Of ten articles appraised, two
included RCTs (Tiainen et al., 2007; Kim et al., 2007); one was quasi-experimental study (Granja
et al., 2011); six were retrospective observational studies (Reinikainen et al., 2012; Prior et al.,
2010; Pfeifer et al., 2011; Testori et al., 2011; Stub et al., 2011; Van der et al., 2011); and one
study had prospective observational design (Storm et al., 2012). Key variables of the research
design and the results of the studies are summarized in Appendix A.
Out of ten studies, five studies (Reinikainen et al., 2012; Prior et al., 2010; Testori et al.,
2011; Stub et al., 2011; Van der et al., 2011) showed statistically significant mortality benefit of
TH. Whereas, of eight studies that evaluated neurological effect of the treatment, four revealed
statistically significant positive conclusion in favor of TH (Prior et al., 2010; Pfeifer et al., 2011;
Testori et al., 2011; Stub et al., 2011). Evidences from the landmark RCTs and this systematic
review concluded that there is a substantial evidence to support the use of TH in post CA cases to
improve survival and neurological outcome. Nevertheless, favorable evidences are more inclined
towards CA patients with shockable rhythm in OHCA. There is limited evidence that support the
use of TH in in-hosptial CA and those with non-shockable rhythm. Those with convincing results
are observational studies in which the risk of bias cannot be eliminated and causality cannot be
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established (Prior et al., 2010; Pfeifer et al., 2011). As a result, TH cannot be concluded as a sole
and independent predictor of positive outcome in in-patients CA cases. However, this review
proclaims the synergic effect of TH with other post ROSC interventions to minimize the
neurological damage and improve survival outcomes in in-patient CA group as well.
All the studies had vast differences in terms of study deign, rigor, and methodology. To
summarize, the studies had limitations like selection bias; lack of control over confounding
variables; inadequate standardization of treatment; lack of power analysis; and influence of
history as a threat to internal, external and statistical validity of the studies (Burns and Grove,
2009). As a result, this review could not conclude the best induction time, optimal duration of TH,
therapeutic range of hypothermia, the rate of rewarming, and the best cooling device to manage
TH. Therefore, expert opinion from ILCOR was referenced to extrapolate the window period for
induction, timelines for maintenance phase and optimal rewarming rate (Nolan et al., 2010).
Theoretical framework
Transformation of practice in lieu of evidences is a complex phenomenon that requires
harmonization between health care system and human being involved in the process (Chapman,
2010). Complex Adaptive Systems (CAS) Theory provides a framework for Clinical Nurse
Specialists (CNSs) through which change is better understood, anticipated, designed and
embraced (Chapman, 2010). According to her, there are three core principles of CAS:
relationships; self-organization; and nonlinear predictability. She elaborates that “CAS is a
collection of individuals, whose actions are interconnected (web of relationships) so that agent’s
action changes the context for other agent (self-organization) with freedom to act in a way that are
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not always totally predictable (nonlinear)” (p.100). The author articulates CAS principles in
following four steps approach to guide CNS while embarking on change process.
According to Chapman (2010), the first step is called assessment, in which change agent
identifies potential stakeholders involved during the change process; explores levels of approval
needed to execute innovation; and recognizes how new proposition articulate with organizational
strategic priority. Second step is referred as diagnosis, in which CNS examines the values and
attitudes of the affected stakeholders about the proposed change; assesses organizational
structure; and identifies potential barriers, facilitators and attractors, to plan and prioritize actions.
In third phase interventions are developed and solutions are tested. This phase involves
development of evidence based standards and guidelines; establishment of multidisciplinary
group to bolster adoption of innovation; development of system level policies to support change,
mobilization of resources to reduce system level barriers; and commencement of methodologies
to sustain the program. In final phase, the impact of the program is evaluated through clinical and
financial outcomes measurement; and findings are disseminated. Chapman (2010) also
emphasizes that CNS competencies defined by The National Association of Clinical Nurse
Specialist (2008) are pivotal to addressing the complex components of CAS.
Intervention
The implementation of the project mimicked the aforementioned steps proposed in CAS
framework. It encompassed need assessment of the institution; multidisciplinary teambuilding;
evidenced based protocol development; establishment of mechanism for process monitoring and
outcome analysis; resource mobilization; clinical capacity building of the nursing staff;
implementation; and measures to ensure sustainability.
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During the need assessment process, keeping in view the culture and work politics of the
institute, influential members were identified necessary for approval, teambuilding and propelling
the agenda forward. The team comprised of CPR committee chair, ICU director, and Assistant
Nursing Director of critical care units. Later, the team also invited the Nurse Manager and
Clinical Nurse Instructor (CNI) of the ICU, who was mainstay to develop a clinical work force.
As a next step, evidences extrapolated through systematic review were utilized to
formulate TH protocol and was discussed with stakeholder. After, deliberation with the CPR
committee chair and ICU director, the protocol was redrafted as a policy document that defined
the responsibilities of multidisciplinary team members (Refer Appendix B). A TH monitoring
sheet was also developed in consultation with CPR committee chair and ICU nursing team, to
meet the monitoring and documentation requirement; and to observe practice variance (Refer
Appendix C). The monitoring sheet also included covariates critical for the outcomes analysis.
Detailed capital and operational budget spread sheet was prepared and presented to the
team to assist in planning and resources allocation (Refer Appendix D). However, keeping in
view that ICU was already well equipped, and a number of services proposed in the TH plan were
rendered as a part of standard ICU care, the final operational cost narrowed down to 325 USD for
the entire treatment, excluding consultation cost. This is far less than one day admission cost of
the ICU.
Afterward, I embarked on training and development of the nursing staff. Three
educational sessions were conducted to prepare the nurses for the required clinical care (n=30).
The first session invited CNI and shift in-charges of the ICU (n=8), who were identified to
become clinical champions of TH. The session was delivered via Skype through real time
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communication. Power point presentation, discussion, case based reflection, skills demonstration,
and ECG simulator were used as teaching methodologies. Skills certification on operation of
cooling device, rectal temperature monitoring, QT analysis, and arrhythmia interpretation was
handled on site by CNI. To assess the learning of student, summative evaluation was conducted
through post-test (Refer Appendix E). Average post test score of 92% compared to pretest result
of 22.9% was appreciating (Refer Appendix F). Course evaluation was also conducted using likert
scale of 1-5 (1= poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent). 87% of the participants
rated the course as excellent and 12.5% scored it very good (Refer Appendix G). Second and third
sessions were conducted onsite by CNI with the assistance of identified champions under my
supervision through Skype. Subsequently, trained nurses would undergo clinical certification on
at least one patient. Additionally, the protocol was also disseminated to the members of CPR and
ICU committee, ICU consultants and residents.
Involvement of clinical and administrative leaders in a TH task force; use of evidence
based recommendations; utilization of policy framework to guide practice; development of
clinical champions; economic operationalization of the project; and mechanisms of outcome
analysis, all these interventions are geared to sustain the program.
Findings
To date, TH has been successfully implemented on one patient and the clinical result has
been appreciating. To evaluate the overall outcome of the pilot project, survival outcomes of all
inductees would be assessed at discharge and at 6 months through physical evaluation and
telephonic follow ups respectively. Thereafter, statistical analysis would be pursuit with the help
of statistician. The survival outcome at discharge would be measured using logistic regression. To
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eliminate the influence of potential confounder or effect modifier on association between TH and
the outcome, adjusted multi-variate logistic regression analysis would also be performed,
controlling for covariates like duration of CPR, initial rhythm, blood glucose level, arterial
oxygen level, and mean arterial pressure, gender, age and acuity level. Additionally, survival
outcome at 6 months would be determined using cox regression analysis adjusted for above listed
variables.
Neurological outcome, which is operationalized by using Pittsburgh Cerebral Performance
Category (CPC) tool, would be analyzed through chi-square. The tool is valid and reliable to
measure the phenomena of interest in post CA cases; is easy to administer on site and over the
phone; and is most frequently used in post CA studies (Tiainen et al., 2007). The above
mentioned findings would also be studied using post hoc stratified analysis to examine the
difference of the outcomes based on shockable and non-shockable rhythm. We also intent to
measure secondary outcomes like length of stay in hospital and cost of care, which would then be
compared with retrospective cases of CA.
Discussion
Therapeutic effects of hypothermia post CA is convincing, but is more pronounced in
patients with shockable rhythm post OHCA. Of 10 studies reviewed, none of the RCTs have
examined the outcome benefit of TH in in-patient CA victims. Only three observational and one
quasi experimental study included both in and OHCA case. Of those, Prior et al’s. (2010) study
revealed statistically significant mortality and neurological benefit and Pfeifer et al’s. (2011)
study showed substantial neurological advantage but only in case of shockable rhythm. Limited
body of knowledge and lower level of evidences supporting the use of TH in non-shockable
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rhythm and in-hospital CA may provoke skepticism and doubts about the benefit of hypothermia
in this group, as both these cohorts may have different acuity level and may respond differently to
post resuscitation care. Thus, there was a concern raised during planning phase as if the evidences
are adequate to support the ethical premises of the project or if ethical approval is warranted for
pilot project. Richardson (2010) guides to the solution of the problem. According to her, the body
of knowledge might be limited or incomplete related to several practice concerns. She suggests
that in such scenario, CNS’s should utilize interventions recommended by expert panel, while
more rigorous research data is available to guide practice. To seek validation, the Hospital’s
Ethics Review Board was also consulted, who also denied the need for ethical approval. However,
we did incorporate informed consent by next of kin as guided by hospital’s consent policy.
Cost implication always surface as a barrier when translating evidences generated from
developed countries to the resource poor health care systems. In most of the studies reviewed, TH
is introduced and controlled through sophisticated auto-regulating cooling system like Arctic-Sun.
Disposable pads of this cooling system alone costs more than total operational cost proposed in
the plan. Similarly, esophageal temperature monitoring system, though not a heavy budget item
was disregarded as an unplanned request in the middle of a fiscal year. Blue and Fisher (2010)
assert that CNS can positively influence health care economy through critical review of
equipment acquired for the patient care. Thus, instead of Arctic-Sun device, I proposed relatively
cost efficient, locally made K-thermia cooling system for temperature maintenance, which is
being used for both cooling and warming purposes for several years in the ICU. The alternate
cooling methodologies are supported by systematic review of Walters et al. (2011), who conclude
that automated cooling systems are not absolute necessity and TH can still be achieved using
conventional cooling measures like chilled intravenous fluid, ice bags and other surface cool
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blankets. Likewise, alternate to esophageal temperature we incorporated rectal temperature
monitoring that is already available in the ICU. This modification was in lieu of Lefrant et al’s.
(2007), who suggest that rectal temperature, though not as precise as esophageal temperature, but
is more reliable than axillary probes to monitor core body temperature.
Change process is often time consuming and exhilarating. The utilization of CAS
theoretical framework invites CNS to critically analyze the situation, organize them and plan
proactively to increase the odds of success while introducing innovation. This framework, if
operationalized in its true sense, has potential to articulate and enhance major key competencies
of CNS like consultation, system leadership, researcher, moral agent, coaching, and collaboration.
(The National CNS Competency Task Force, 2008)
Conclusion
This project will mark a beginning for several events at AKUH. The pilot project has not
only introduced the novel evidence based intervention for post CA patients, but has also
ameliorated the outcome monitoring system of resuscitation service at AKUH. In next one year
time, this pilot project would hopefully produce substantial data to support replication in other
unit and in other hospitals of Karachi. In addition, this initiative is one of its kinds to support the
notion of having masters prepared CNSs in the institution to promote the culture of evidence
based nursing practice.
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Appendix A
Summary of Evidences
1st
Study design
/Control/LOE
Author
Sample
Type of
CA rhythm
Site of
CA
Cooling
device
TH vs NT
Induction
time from
ROSC
Target temp
in TH group
/Mean temp
Cooling
duration
Mean
temp in
NT group
Survival Outcome
Neurological Outcome
TH vs NT
TH vs NT
Tiainen
(2007)
Randomized
prospective
trial
(I B)
N = 70
TH = 36
NT= 34
Shockable
*OHCA
External
device
NA
32-34C/
33+1C
24hrs
Mean NA
^NT
Mean NA
Kim
(2007)
Randomized
controlled
trial
(I C)
N = 97
TH = 49
NT = 48
All
rhythms
*OHCA
SC and
CS
NA
32-34C/
Mean NA
NA
×NT
Mean NA
[SO] VF group:
66% vs 45%, p= NS
Non VF group:
6% vs 20%, p = NS
Adjusted OR for survival =
0.91, 95% CI=0.28 to 2.96
Awakening in VF
patients:
69% vs 45%, P = 0.15
Awakening in Non-VF
patients:
9% vs 23%, P = 0.13
Granja
(2011)
Before and
after
(II B)
N = 130
TH = 55
NT =75
All
rhythms
IN and
**OHCA
SC and
CS
4+2.25hrs
32-34C/
Mean NA
15.1+4.1
hrs
×NT
Mean NA
[SO] 60% vs 39% ,P= 0.16
26 vs 21 patients, NS
Reinika
inen
2012
Retrospective
observational
with HC
(III B)
N = 3958
TH = 3072
NT = 886
Shockable
OHCA
NA
NA
NA
32-34C/
Mean NA
NA
×NT
Mean NA
[M]51.1% vs 57.9%, P< 0.001
Adjusted OR = 0.54, 95 % CI=
0.45-0.64, P < 0.001)
NA
Prior
(2010)
Retrospective
cohort with
HC
(III B-/C)
N = 456
TH = 44
NT = 368
All
rhythms
IN and
**OHCA
SC
2.8hrs
(0.2-7.8
32-34C/
Mean NA
9-28hrs
×NT
Mean NA
[SO] Within TH group:
Shockable vs non shockable
61% vs 24%, P < 0.05
43% vs 13%, P < 0.001
Pfeifer
(2011)
Retrospective
observational
with HC
(III B)
N = 210
TH = 143
NT = 67
All
rhythms
IN and
**OHCA
SC and
CS
4-6hrs
32-34C/
33+1C
24hrs
Mean NA
^NT
Mean NA
[SO] All patients:
48.2% vs 44.8%, P = 0.659
For shockable :
26.4% vs 28.6%, P = 0.807
For non-shockable:
70.4% vs 56.4%, P = 0.149)
Better in VF patient
within TH group (p <
0.001)
Testori,
Retrospective
N = 374
Non
*OHCA
SC and
1.4hrs
32-34C/
24hrs
^^NT
[SO] ( 28 vs 22, p = 0.226)
[SO] Adjusted OR = 0.56, 95%
93% vs 78%, no P value
Cognitive outcome:
Intact or subtle deficit
67% vs 44%, NS
Adjusted OR = 1.84,
APPENDIX
(2011)
Storm
(2012)
cohort with
HC
(III B)
Prospective
observational
with HC
(III B)
TH =135
NT= 239
Shockable
N = 175
TH = 87
NT = 88
Non
Shockable
CS
IN and
**OHCA
SC and
CS
NA
33+1C
Mean NA
Mean NA
CI, 0.34 – 0.93
95% CI, 1.08 – 3.13
32-34C/
Mean NA
24hrs
Mean NA
×NT
Mean NA
[SO] Adjusted HR 0.98, 95%
CI = 0.53-1.5, p = 0.63
27.5% vs 18.2%, P =
0.175
Stub
(2011)
Retrospective
N = 125
Shockable **OHCA
SC and
NA
NA
×NT
[SO] 64% vs 39%, p <0.01
57% vs 29%, p < 0.01
32-34C/
observational
TH = 81
CS
Mean NA
Unadjusted Odds ratio 2.7,
Mean NA
with HC
NT = 44
95% CI = 1.1 – 6.4 , P = 0.02
(III B)
Van der Retrospective
N = 5317
All
**OHCA
NA
NA
NA
^^NT
[M] 65% vs 72%, p = NA
NA
33-36.4C
(2011)
observational
TH= 3770
rhythms
Mean NA Adjust OR= 0.8, 95% CI= 0.65
with HC
NT = 1547
– 0.98, p = 0.29
(III B)
LOE= Level of evidence; CA=Cardiac arrest; ROSC=Return of spontaneous circulation; SO=Survival Outcome; M=Mortality Outcome; All rhythms= VT/VF/PEA/Asystole;
TH=Therapeutic hypothermia; Shockable =VT/VF; Non Shockable=PEA/Asystole; NT=Normothermia; ^ hyperthermia controlled; ^^ hyperthermia not controlled; × hyperthermia
information NA; *OHCA=Out of hospital cardiac arrest(witnessed); **OHCA=Out of hospital cardiac arrest(witnessed and un witnessed);IN=In-hospital; NS=Not significant; NA=Not
available/assessed; SC=Surface cooling; CS=cold saline/fluids; R=hazard ratio; HC=Historical control
Appendix B
Policy Title: Therapeutic hypothermia in adult post cardiac arrest patients
I.
POLICY STATEMENT
The policy provides guidelines for the use of therapeutic hypothermia in adult patients who
have sustained cardiopulmonary resuscitation with a return of spontaneous circulation
(ROSC).
II.
PURPOSE
The purpose of therapeutic hypothermia is to minimize post cardiac arrest brain injury in
order to improve neurological and survival outcomes of post cardiac arrest patients.
III.
APPLICABILE TO
a) The policy applies to patients arriving in ICU through ER or in-patient units who
sustained witnessed or un-witnessed cardiopulmonary arrest and meet inclusion and
exclusion criteria for therapeutic hypothermia.
b) Therapeutic hypothermia should not be initiated in uncontrolled settings like general
ward, special care unit or emergency department.
IV.
DEFINITIONS
a) Therapeutic hypothermia: Is a controlled lowering of patient’s core temperature to 32C
– 34C ( 33C).
b) Core temperature: Represents temperature of internal visceral organs. Typical
measurement sites are rectal, pulmonary artery catheter (PAC), esophageal and bladder.
c) Peripheral temperature: Sources of peripheral temperature monitoring include oral and
axillary routes. They can be used to estimate core temperature with a consideration that
peripheral temperature reading may lag behind core temperature changes.
d) Rewarming: Is a passive return of body temperature to 36C.
V.
INDICATIONS
a) Inclusion criteria:
i. Adult patients (over age of 18years) whose initial cardiac arrest rhythm is Ventricular
Fibrillation (VF) or Pulseless Ventricular Tachycardia (VT). Patients who had
Pulseless Electrical Activity (PEA) and Asystolic arrest may also benefit from the
therapeutic hypothermia and should be considered for the therapy.
ii. ROSC following CPR within 60 minutes of collapse.
iii. Persistent coma following ROSC. It is defined as inability to follow commands which
is not attributed to pre-cardiac arrest medical condition.
Appendix B
b) Exclusion criteria:
i.
Shock that is refractory to vasopressors, is a relative contraindication to therapeutic
hypothermia.
ii.
Patients with terminal illness or multi-organ dysfunction.
iii.
Therapeutic hypothermia should not be offered to patients with following clinical
manifestations.
 Persistent life threatening arrhythmias post ROSC
 Pregnancy
 Time laps of more than 12 hours from ROSC
 Pregnancy (All female patients of child bearing age must be checked for urine
hCG)
 Primary coagulopathy or uncontrolled bleeding.
 Patients with DNR.
 Patients with no flow time more than 60 minutes
 Patient with traumatic brain injury
Note: Patients who have received thrombolytic agents or who are on antiplatelet/anticoagulant
therapy as deemed necessary to treat a primary cardiac condition, is not a contraindication to
cooling.
VI.
RESPONSIBILITY
a) ICU Medical/Anesthesia team
i.
ii.
iii.
iv.
v.
vi.
ICU intensivist/resident would determine the appropriateness of therapeutic
hypothermia use for an individual patient against the set inclusion and exclusion criteria
at the time of ICU admission.
ICU intensivist/ ICU resident would communicate primary team and patient’s family
members about the purpose of the treatment and would obtain written consent from the
family.
ICU intensivist/ ICU resident would ensure that the base line clinical assessment is
done; ECG is reviewed for QT interval and arrhythmia; and required lab investigations
are followed.
ICU resident would prescribe the written order for therapeutic hypothermia, cold
normal saline /ringers lactate infusion, sedation and muscle relaxant as indicated.
ICU resident would insert arterial and central line for monitoring.
ICU intensivist/ ICU resident would perform reassessment and manage complications
associated with therapeutic hypothermia.
b) ICU Nursing Team
Appendix B
i.
ii.
iii.
iv.
ICU head nurse (HN) /clinical nurse instructor (CNI)/team leader would determine at
the time of booking if patient is a potential candidate for therapeutic hypothermia,
would inform ICU resident and would expedite the transfer process.
Nurses who have attended unit specific training on therapeutic hypothermia will be
responsible to implement the protocol in conjunction with head nurse/clinical nurses
instructor/team leader and ICU consultant/resident.
Assigned nurse would ensure that assessment time lines and monitoring
recommendations are followed during pre-indication, induction, maintenance and
rewarming phase.
Assigned nurse would ensure that documentation is done as per defined frequency.
c) CPR Committee
i.
VII.
CPR committee chair/co-chair in coordination with ICU medical director, nurse
manager/ CNS would be responsible to oversee the quality assurance issues related to
therapeutic hypothermia, monitor neurological and survival outcomes of patients and
present trends to the leadership.
PROCEDURE
a) General guidelines
i. The patient must be intubated, mechanically ventilated and on continuous cardiac
monitoring.
ii. Cooling should be initiated as soon as possible, preferably within 4-6 hours of ROSC.
iii. Patient should be cooled as soon as possible to achieve the target temperature of 32C –
34C ( 33C) within 4-6 hours of initiation of initiating cooling measures.
iv. Target temperature should be maintained for 24 hours, with time beginning once patient
reaches the goal temperature.
v. To optimize the positive outcomes of the hypothermia take measures to maintain MAP
65-100mmHg; urine output > 0.5 ml/kg; CVP 8-12 mmHg; PaO2 between 80100mmHg,O2 saturation 94%-96%; control hyperglycemia following target blood sugar
between 110-140 mg/dl.
b) Pre induction phase
i.
ii.
iii.
iv.
Establish most appropriate method for continuous temperature monitoring that is
rectal, bladder, esophageal or pulmonary artery catheter (PAC). Peripheral temperature
should only be used as secondary source to verify temperature and should not be used
to guide the therapy.
Assess and document patient’s baseline neurological status, vital signs and CVP
reading.
Obtain base line lab for blood sugar, serum electrolyte, arterial blood gas, coagulation
profile and serum lactate.
Obtain rhythm strip to determine baseline QT interval and assessment of arrhythmias.
Appendix B
v.
vi.
Ensure that central line is inserted for volume status monitoring and arterial line is
available for blood pressure monitoring and sampling. However, induction of
therapeutic hypothermia should not be delayed if the lines are not in place.
Note: Arterial line access may be more difficult to obtain due to vasoconstriction,
once the target temperature is reached.
ETCO2 monitoring may be used to monitor variation in PCO2 during the treatment.
c) Initiation/Induction phase
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
Administer chilled (cooled at approximately 4C) Normal Saline or Ringers Lactate
that is equal to 30ml/kg over 30 minutes through a peripheral line, after obtaining
physician’s order.
Assess for evidence of pulmonary edema before, during and after administration of
fluid.
Avoid using internal jugular or subclavian CVP lines to infuse cold infusion.
However, femoral CVP can be used for the same.
Initiate surface cooling device (K-thermia) with the goal temperature set on the
machine to prevent over cooling. Ensure that water level in K-thermia is filled and
device is operated as per manufacturer’s recommendation.
Apply ice packs to the neck, torso, armpits, flanks and groin. This method can be used
in conjunction with other cooling measures to facilitate the induction process and to
attain the goal temperature in a recommended time period.
During this phase, continuously monitor patient’s temperature, blood pressure, heart
rate and O2 saturations and document every 15 minutes in therapeutic hypothermia
monitoring form (Form is in process of development)
Monitor CVP and urine output every hour.
Assess patient for shivering every hour using Bed Side Shivering Assessment Scale
(BSAS). Notify physician if score is more than 0. Use non-pharmacological measures
like socks or stocking on the feet and hands.
BSAS
SCORE
0
None
1
Mild
2
Moderate
3
Severe
ix.
x.
DEFINITION
No shivering noted on palpation of the masseter, neck or chest wall
and absence of ECG artifacts.
Shivering localized to neck and/or thorax only. May only be noticed
on palpation of or by the presence of ECG artifact.
Shivering involves gross muscle movement of upper extremities in
addition to neck and thorax .
Shivering involves gross movement of the trunk and upper and lower
extremities
Patient should be administered opioids analgesia (fentanyl, morphine sulphate) and
hypnotics (propofol) or benzodiazepine (midazolam) to prevent shivering.
If shivering occurs despite optimal sedation, neuromuscular blocking agent
(pancuronium, vecuronium, atracurium) as a bolus or infusion should be considered.
Beware that the duration of action of neuromuscular blocking agent is prolong during
hypothermia.
Appendix B
xi.
xii.
xiii.
xiv.
In case of refractory shivering Magnesium Sulphate may be considered.
Train of Four must be used for patient receiving neuromuscular blockade to prevent
under or over dosing of paralytic agent (recommended blockade is 2 out of 4 twitches).
Assess patient’s skin integrity every 2 hourly.
Monitor and document the temperature reading of the K-thermia every hourly
d) Maintenance phase
i. Once the target temperature 32C – 34C (33 C) is achieved, hold cooling measures
except for K-thermia.
ii. Maintain temperature 32C – 34C (33 C) for 24 hours, with time beginning once
patient reached the goal temperature.
iii. If the temperature rises above 34C during this phase, ice packs may be reapplied to
bring temperature to the required range.
iv. K-thermia must be stopped if the temperature falls below recommendation range.
v. Continuously monitor patient’s temperature, blood pressure, heart rate, and O2 sats at
least every 30 minutes.
vi. Pulse oximetry, commonly monitored in the digits, can be inaccurate and unreliable due
to vasoconstriction. Thus, an alternate sources like forehead sensor, or ear probe should
be used.
vii. Monitor CVP and urine output every hour as per ICU protocol.
viii. Check placement of rectal temperature probe every 2 – 4 hourly and verify the
temperature through secondary temperature source.
ix. Check skin integrity every 2 hourly.
x. Assess for shivering at least 2 hourly and PRN during the maintenance phase by using
BSAS. Notify physician if the score is more than 0. Manage shivering as described in
the induction phase.
xi. Continue to document temperature reading on the K-thermia every hourly.
xii. Monitor patient for following adverse effects during this phase.
xi-a) Bradycardia: often results with cooling process and is usually refractory to
atropine. Intervention may not be needed unless it is associated with hemodynamic
instability.
xi-b) QT prolongation: QT should be monitored and documented every 4 hourly during
this phase. If corrected QTc is greater than 500ms or 0.5sec, the physician should be
notified immediately, as it may cause Torsades de pointes.
Caution: If treatment is aborted due to persistent arrhythmia, rapid rewarming must be
avoided. Patient should be rewarmed following the rewarming guidelines.
xi- c) Hyperglycemia: hypothermia decreases insulin sensitivity and secretion and
causes hyperglycemia. Monitor blood glucose every 2-4 hourly as per patient’s baseline
or ICU protocol. If hyperglycemia develops, monitor blood glucose every hourly and
initiate insulin therapy as per physician’s order.
Note: Due to peripheral vasoconstriction, capillary glucose measurements during
hypothermia can be inaccurate. Therefore, it is advised to obtain blood glucose levels
using arterial or central line and verify with lab glucose value prior to insulin treatment.
Appendix B
xi-d) Electrolyte imbalances: Hypokalemia, hypomagnesemia, hypocalcemia, and
hypophosphatemia can occur during cooling phase due to intracellular shift of
electrolytes. Check electrolyte every 6-8 hourly or as ordered.
Note: Electrolyte shift reverses when the patient is rewarmed.
xi-e) Coagulopathies: may occur with hypothermia. Ensure that patient is monitored for
signs of bleeding. Apply adequate pressure if new arterial or venipuncture is performed
during cooling phase. Check coagulation profile every 12 hour or as ordered. Platelet
and coagulation correction would be at the discretion of ICU physician.
xi-f) Volume depletion: Hypothermia induced diuresis may occur causing volume
depletion. Monitor and document CVP and urine output every hourly along with other
hemodynamic parameter. Maintain adequate hydration as per physician order.
e) Rewarming phase
i. Rewarming phase begins upon completion of 24 hours of maintenance phase.
ii. ICU consultant/ resident must be notified when rewarming is initiated.
iii. Turn off all cooling measure and let the patient rewarm passively to a temperature of
36C. Remove wet sheets and apply blankets, socks and stocking to facilitate warming
process.
iv. Passive rewarming may take 8-12 hour. Temperature rise should not be faster than
0.25 - 0.5 C per hour.
v. Monitor patient’s temperature, blood pressure, heart rate, and O2 sats and document
every 30 minutes.
vi. Use of K-thermia or bair hugger should only be reserved if temperature does not rise
as per recommendation in initial 6 hours of rewarming phase. Ensure that rewarming
does not exceed 0.5 C per hour if any of these devices are used.
vii. Monitor and document the temperature readings of K-thermia/Bair Hugger every
hourly if it is used to facilitate rewarming.
viii. K-thermia/Bair Hugger and all other measures must be stopped once patient’s
temperature reaches 36C.
ix. Closely monitor patient for following adverse effects during this phase.
ix-a) Hypotension: Vasodilation during rewarming phase may cause hypotension.
Administered fluid as per physician’s order to keep MAP above 60mmHg.
ix-b) Hyperkalemia: Monitor patient for signs of hyperkalemia that may occur due to
extracellular shift of electrolyte.
x. Sedation and/or neuromuscular blocking agent (if started earlier) should be maintained
till temperature of 36C is achieved. Thereafter, sedation and muscle relaxant can be
stopped upon discretion of ICU physician.
xi. Efforts must be made to prevent pyrexia (38C) during initial 72 hours from the time
of cardiac arrest.
References.
References are already list under the assignment section.
Developed By: Roshan Jan Muhammad
Appendix C
The Aga Khan University Hospital
Division of Nursing Services
Therapeutic hypothermia monitoring sheet
Date of cardiac arrest: ____________________
Time of cardiac arrest: ____________________
Duration of code: ________________________
Time of return of ROSC: ___________________
Location of cardiac arrest:  Out of hospital
 In-hospital ______
Witnessed:  Yes
 No
Initial Rhythm Requiring Chest Compressions:
 PEA
 Asystole  Ventricular Tachycardia
 Torsades de pointes  Ventricular Fibrillation
Time
38.0
37.5
37.0
36.5
36.0
35.0
34.5
34.0
33.8
33.6
33.4
33.2
33.0
32.8
32.6
32.4
32.2
32.0
31.0
S PO2
SBP
DBP
MAP
CVP
Reflo
QT
Pre therapeutic hypothermia checks
Consent __________ Primary team notified__________
GCS: E___M___V___.
Pupils (Size and reaction)R________ L _________
ECG rhythm:____________________ QT interval: ____
Sr. K _______ Sr. Mg _______Sr. Ca ________
Sr. Lactate__________Blood sugar __________
CVP_______________ MAP________________
CPC Score at discharge_________ 6 months ________
Therapeutic Hypothermia Summary
Induction time ______ Time target temperature achieved___
Duration of maintenance phase: ___________
Duration of rewarming phase: ____________
Appendix C
Shivering Assessment
Time
Shivering score
Measures taken
Cooling Techniques
Time
Cold NS/RL
Ice packs
K-thermia (Temp)
Time
38.0
37.5
37.0
36.5
36.0
35.0
34.5
34.0
33.8
33.6
33.4
33.2
33.0
32.8
32.6
32.4
32.2
32.0
31.0
S PO2
SBP
DBP
MAP
CVP
QT
Shivering Assessment
Time
Shivering score
Measures taken
Key for measures taken: SB (sedation bolus) SII(Sedation infusion incremented), MB(Muscle relaxant bolus), MgSO4, NPM (Non-pharmacological measures)
Cooling Techniques
Time
Cold NS/RL
Appendix C
Ice packs
K-thermia (Temp)
Lab Investigations
Date/Time
Blood Sugar
Potassium
Calcium
Magnesium
Phosphate
Platelet
PT/INR
APTT
Note: The image and the format of the form has distorted during transfer of content
Appendix D
Budget for therapeutic hypothermia service per patient
Capital Cost
Brand
Philips
Kthermia
Grasbey
Equipment
Rectal temperature
probes
Cooling device
Infusion pump
Lab investigations
-
Serum Lactate
CBC
-
Basic metabolic panel +
Mg and phosphate
Coagulation profile
(PT/APTT/INR)
Blood sugar (Finger
stick)
ECG
-
Medications
-
No of
units
required
1
1
1
Cost per
unit ($)
Total
cost
300.00
300.00
2500.00
2500.00 Yes
2000.00
Operational Cost
2000.00 Yes
Total
cost per
Total
Frequency frequency
cost
($)
2
8
16
4
10
40
4
25
100
4
10
40
12
1
12
2
10
20
Quantity
Cost per
unit
5
Total
cost
5
200
Total
cost
76
Normal Saline drips (1
Liter)
Sedation/muscle relaxant
Monitoring services
1
Arrow
Arterial line
1
variable
Cost per
unit
76
BD
CVP line (triple lumen)
1
45
45
BD
Pressure transducer
system for arterial line
and CVP monitoring
Arterial line and CVP
insertion cost
1
150
150
1
100
100
-
-
Already available in
the ICU
variable
Quantity
Yes
Part of standard ICU
Care
Yes
Once per day is
standard of care in ICU
Twice per day is
standard of care in ICU
Once per day is
standard of care in ICU
Six per day is standard
of care in ICU
Once per day is
standard of care in ICU
Part of standard ICU
Care
Yes
Variable
Part of standard ICU
Care
Standard of care in
ICU
Standard of care in
ICU
Standard of care in
ICU
Standard of care in
ICU
Total Operational cost = 804
Total Operational Cost Excluding Standard ICU Care Elements = 325
.
Service
-
Telephonic consultation
of CNS and training
hours
Others
Total
charges
Hours
per hour
20 hours
40 dollars
per hour
total
charges
800
No
Note:
The capital cost is proposed to offer hypothermia treatment to 2 patients at any given time.
Depreciation and recovery elements are not incorporated which are part of detailed financial
feasibility report otherwise. For the project, no new items were needed to be purchased as the
required items were already available.
Operational item list is not exhaustive. Total cost of USD 804 incudes services that are part of
routine ICU care regardless of therapeutic hypothermia intervention, therefore, numbers should be
interpreted carefully as they are projected for future reference if the service replication is intended
in future to the other units.
Appendix E
Therapeutic Hypothermia Training
Pre and Post Test
1. It is a Class I recommendation of the American Heart Association (AHA) to induce therapeutic
hypothermia in adults following cardiac arrest to temperatures of
a) 86.0°F (30°C) to 89.6°F (32°C)
b) 87.8°F (31°C) to 91.4°F (33°C)
c) 89.6°F (32°C) to 93.2°F (34°C)
d) 91.4°F (33°C) to 95.0°F (35°C)
2. This Class I recommendation of the AHA includes maintaining therapeutic hypothermia for
how many hours?
a) 2 to 4
b) 4 to 8
c) 8 to 12
d) 12 to 24
3. Induced hypothermia is contraindicated in patients who have
a) intracranial hemorrhage.
b) myocardial infarction.
c) atrial fibrillation.
d) diabetes mellitus.
4. During the induction stage, acceptable invasive methods include rapidly infusing lactated
Ringer’s solution that has been cooled to
a) 37.4°F (3°C)
b) 39.2°F (4°C)
c) 41.0°F (5°C)
d) 42.8°F (6°C)
5. Which of the following invasive lines cannot be used to infused cold saline or Ringers
Lactate
a) Peripheral lines
b) Central Venous catheter in femoral vein
c) Central venous catheter in jugular vein
d) None of the above
6. Which of the following is not a preferred means of monitoring the temperature of a patient
undergoing therapeutic hypothermia is with which type of thermometer.
a) Axillary
b) Esophageal
c) Rectal
d) Bladder
7. Patient undergoing therapeutic hypothermia are typically rewarmed over how many hours?
APPENDIX E
a) 8-12 hours
b) 4-6 hours
c) 6-8 hours
d) 12-24 hours
8. Therapeutic hypothermia is most beneficial if it is introduced within _________time of return
of spontaneous circulation.
a) 4-6 hours
b) 6-12 hours
c) 12-24 hours
d) > 24 hours
9. Which of the following are the side effects during maintenance phase of therapeutic
hypothermia. (Select all that applies)
a) Bleeding
b) QT prolongation
c) Hypomagnesemia
d) Hyperkalemia
e) Bradycardia
f) Tachycardia
g) Hypotension
h) Hyperglycemia
i) Shivering
j) Diuresis
10. Which particular rhythm disturbance is most likely to develop during maintenance phase of
therapeutic hypothermia
a) Atrial fibrillation
b) Bradycardia
c) Junctional tachycardia
d) Ventricular fibrillation
11. Which of the following are not candidates for therapeutic hypothermia. (Select all that
applies)
a) Persistent life threatening arrhythmias post ROSC
b) Pregnancy
c) Time laps of more than 12 hours from ROSC
d) Primary coagulopathy or uncontrolled bleeding.
e) Patients with no flow time less than 60 minutes
f) Patient with traumatic brain injury
12. Which of the following is the side effects during rewarming phase of therapeutic hypothermia.
(Select all applicable)
APPENDIX E
a) Bleeding
b) QT prolongation
c) Hypomagnesemia
d) Hyperkalemia
e) Bradycardia
f) Hypotension
13. Patient undergoing therapeutic hypothermia are typically rewarmed not more than
a) 0.25 C per hour.
b) 0.25 - 0.5 C per hour
c) 0.5 - 0.75 C per hour.
d) 0.75 – 1.0 C per hour.
14. Bedside nurse palpates the patient and notices shivering that is localized to neck and/or thorax
along with presence of ECG artifact. How would you rate the shivering using bedside
shivering scale.
a) Grade 0
b) Grade I (Mild)
c) Grade II (Moderate)
d) Grade III (Severe)
15. Which of the following is considered shivering prophylaxis for hypothermia patients
a) Opioids analgesia, hypnotics or benzodiazepine
b) Opioids analgesia, neuromuscular blocking agent
c) Neuromuscular blocking agent, Magnesium sulphate
d) Opioids analgesia, Magnesium Sulphate
Appendix F
Pre and Post test Comparison
Questions
Pre test
It is a Class I recommendation of the American Heart Association (AHA)
25
to induce therapeutic hypothermia in adults following cardiac arrest to
temperatures of
This Class I recommendation of the AHA includes maintaining
12.5
therapeu¬tic hypothermia for how many hours?
Induced hypothermia is contraindicated in patients who have
25
During the induction stage, acceptable invasive methods include rapidly
0
infusing lactated Ringer’s solution that has been cooled to
Which of the following invasive lines cannot be used to infused cold saline 50
or Ringers Lactate
Which of the following is not a preferred means of monitoring the
37
temperature of a patient undergoing therapeutic hypothermia is with which
type of thermometer
Patient undergoing therapeutic hypothermia are typically rewarmed over
25
how many hours?
Therapeutic hypothermia is most beneficial if it is introduced within
0
_________time of return of spontaneous circulation.
Which particular rhythm disturbance is most likely to develop during
37
maintenance phase of therapeutic hypothermia
Which of the following is the side effects during rewarming phase of
25
therapeutic hypothermia. (Select all applicable)
Patient undergoing therapeutic hypothermia are typically rewarmed not
0
more than
Bedside nurse palpates the patient and notices shivering that is localized to 37
neck and/or thorax along with presence of ECG artifact. How would you
rate the shivering using bedside shivering scale.
Which of the following is considered shivering prophylaxis for
25
hypothermia patients
Average Score
22.96
Which of the following are the side effects during maintenance phase of
NA
therapeutic hypothermia. (Select all that applies)
Which of the following are not candidates for therapeutic hypothermia.
NA
(Select all that applies)
Note: Last 2 questions were not included in the analysis because of multiple correct
answers.
Post test
100
100
87
100
87
87
75
100
87
100
87
87
100
92.07
NA
NA
Appendix G
Course Evaluation Summary
Questions
Poor
Fair Good V.Good Excellent TOTAL
Language was clear and understandable
Presenter was knowledgeable and confident
Presentation content was clear and
understandable
Presenter was able to facilitate your
learning
Various teaching methods were used
Discussion was encouraged
Presenter was able to hold your interest
Presenter was sensitive towards individual
learners' needs
Time was utilized effectively
Presenter was well planned and organized
Did this presentation prepare you
adequately to implement therapeutic
hypothermia on patient
Overall rating for the course
Percentage of overall rating
0
0
0
0
0
0
0
0
0
0
0
0
8
8
8
8
8
8
0
0
0
0
8
8
0
0
0
0
0
0
0
0
0
0
0
0
1
1
0
1
7
7
8
7
8
8
8
8
0
0
0
0
0
0
0
0
0
0
0
3
8
8
5
8
8
8
0
-
0
-
0
-
1
12.5%
7
87%
8
-