PHAST Protocol
Version 12/01/2015
Pre-Hospital Advanced Airway Management in the Nordic Countries
– A Prospective Multicentre Observational Study
Principal Investigator
Professor Hans Morten Lossius, MD, PhD
Head of Research, Norwegian Air Ambulance Foundation, Norway
Investigators
Dan Gryth, MD, PhD, Unit Manager, Prehospital/Catastrophe Medicine Unit, Karolinska University Hospital
Professor Christer Svensén, MD, PhD, Head of Doctoral Education, Karolinska Institutet/SÖS, Sweden
Mikael Gellerfors, MD, Karolinska Institutet, Sweden1
Leif Rognås. MD, PhD, Lead Clinician, The Prehospital Critical Care Service, Aarhus, Denmark
Soren Mikkelsen, MD, Lead Clinician, The Prehospital Critical Care Service, Odense, Denmark
Espen Fevang , MD, Norwegian Air Ambulance, Stavanger, Norway
Andreas Krüger, MD, PhD, Norwegian Air Ambulance, Trondheim, Norway
1
24/7 Contact: Mikael Gellerfors, Anaesthesiology & Intensive Care Department, Södersjukhuset,
Sjukhusbacken 10, 118 83 Stockholm, Sweden, E mikael.gellerfors@sodersjukhuset.se M +46-70-7711133
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1. EXECUTIVE SUMMARY
Background
Pre-Hospital Advanced Airway Management (PHAAM) is a potentially
lifesaving intervention. A recent Danish multicentre single country study
demonstrated a 99,7% incidence of successful anaesthesiologist prehospital endotracheal intubation, with a PHAAM related complication
rate of 7.9%. A London study revealed a significantly higher intubation
failure rate among non-anaesthesiologist physicians. In Scandinavia
different types of emergency medical services (EMS) and professions
provide PHAAM. The success rate of prehospital endotracheal intubation
(PHETI), incidence of difficult intubation and complications in the
Nordic countries is not known.
Aim
Define PHAAM success rate and complications in different types of
Nordic EMS organisations and physician critical care teams.
Population
Multicentre PHAAM study with 12 participating EMS/HEMS centres
and physician critical care teams in the Nordic countries.
1° endpoint
Overall PHETI success rate
Design
Prospective observational study with collection of PHAAM data
according the template by Sollid et al.
Significance
First large Nordic multicentre study on PHETI success rate and
complications.
2. BACKGROUND
2.1 Prehospital Intubation
Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving
intervention.1 However, the pre-hospital setting is challenging with less optimal endotracheal
intubation (ETI) conditions as regards to patient positioning, airway obstruction, equipment,
light and assistance. PHAAM carries a risk of serious complications that may threaten patient
safety and worsen patient outcome.2 3 4 Since pre-hospital ETI (PHETI) carries a risk of
severe adverse events if not performed correctly, its providers must be both technically
competent to perform the procedure and capable of making decisions and initiate treatments
to prevent and treat complications.5 The incidences of complications related to PHAAM are
not negligible even for physician-staffed systems and it is important that the pre-hospital care
provider can promptly identify the patients most likely to benefit from PHAAM.6 7 8 9
In the last decade there has been a rapid development of methods and devices facilitating the
pre-hospital airway management. Among others, indirect laryngoscopy, mainly by video
sights, has become more frequent. Video laryngoscopes improve visualisation of the airway
and may increase the overall intubation success rate. The GlideScope Ranger video
laryngoscope demonstrated a 97% success rate in 315 patients undergoing out-of-hospital
intubation.10
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2.2 The Scandinavian Pre-hospital Setting
Although the EMS structure in Scandinavia is reasonably similar, there are some inter- and
intra-national differences regarding mission profile, systems for dispatch, response and onscene management.11 Some regions use ground ambulances staffed by a nurse with additional
EMS training and a driver with basic emergency training. Other Scandinavian regions utilize
a two-tiered EMS system. The first tier consists of road ambulances staffed by a nurse with
additional EMS training and a driver with basic emergency training. The second tier consists
of pre-hospital critical care teams staffed with physicians, usually experienced
anaesthesiologists.12 In some regions the second tier consists of non-physicians, for example
nurse anaesthetists and paramedics.
In a study of 16 Scandinavian anaesthesiologist-staffed pre-hospital services 4236 alarm calls
resulting in 2256 patient encounters, 23% of the patients had severely deranged vital
functions.11 The probability that the patient was physiologically deranged, received advanced
medication, or procedure was 35%. Medical aetiology was observed in 14.9 and trauma in 5,6
per 10,000 person-years. The authors concluded that the Scandinavian pre-hospital population
incidence of critical illness and injury is 25–30 per 10,000 person-years. The number of
patient encounters varied significantly between the studied nations (Denmark 74.9, Finland
14.6, Norway 11, and Sweden 5 patient encounters per 10,000 person-years).
Most of the pre-hospital physicians work part-time in hospitals and are very experienced in
intubation procedures.13 They are also familiar with and regular users of indirect laryngoscopy
techniques such as GlideScope, Storz C-MAC, McGrath and/or Airtraq. 14 15
2.3 Previous Studies of Non-Physician and Physician Staffed EMS/HEMS PHETI
In the literature it is generally reported that the airway management performance of physicianstaffed EMS / HEMS 7 16 17 18 19 20 21 22 23 24 25 seems to be of a higher standard compared
with that of non-physician-staffed pre-hospital systems. However, the risks and complications
related to PHAAM in physician-staffed pre-hospital systems also appear to be significant and
dependent on level of expertise of the physician.21 24 The incidence of failed pre-hospital
endotracheal intubation (PHETI) in physician-staffed EMS/HEMS is reported to be 1-2% by
several authors16 17 18 19 21 22 24 including a meta-analysis by Lossius et al.20
In the meta-analysis by Lossius et al 58 original studies of 1,070 met the inclusion criteria,
20
with 33 studies reporting ETI success rates.
In total, ETI was attempted in 15,398 patients,
2,536 by physicians and 12,862 by non-physicians. The median (range) reported success rate
was 0.905 (0.491, 1.000) with estimated overall ETI success rate was 0.927 (95% CI, 0.882,
0.961). When comparing physicians to non-physicians, the corresponding median (range) ETI
success rates were 0.991 (0.973, 1.000) versus 0.849 (0.491, 0.990). All seven physicianmanned services reporting success rates also reported availability of drugs for intubation on
scene (all used standard RSI). Of the 26 non-physician-manned services reporting success
rates, 19 (73%) reported drugs available on scene, leaving seven services reporting no use of
drugs (drug group 1). Of the 19 services reporting use of drugs, six had analgesics,
anaesthetics or a combination of both (drug group 2), and 13 also reported having muscle
relaxantia, with or without analgesics or anaesthetics, or standard RSI available (drug group
3). In drug groups 1, 2 and 3, the reported median (range) ETI success rates for non-
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physicians were 0.675 (0.491, 0.968), 0.810 (0.755, 0.905) and 0.967 (0.758, 1.000),
respectively.
In a recent prospective Danish multicentre Utstein-style study PHAAM by anaesthesiologists
was investigated.6 The overall incidence of successful pre-hospital endotracheal intubation
among 636 intubation attempts was 99.7% (first pass success 77,6%) with an overall PHAAM
related complication incidence of 7.9%. The incidence of 0.3% failed pre-hospital
endotracheal intubations (PHETI) compares to those reported from other physician-staffed
EMS / HEMS in the London/UK17 24, Germany21 and France16. The overall incidence of
difficult PHETI was 22.4%.
The ongoing European AIRPORT study includes patients from physician staffed HEMS/EMS
units in Finland (Kupio, Vantaa and Tampere) and Norway (Oslo, Bergen, Stavanger,
Tromsø, Trondheim, Ål and Arendal). There are no HEMS/EMS centres from Sweden,
Denmark and Iceland in the AIRPORT study. Consequently, no conclusions can draw about
the PHAAM success rate and complications in the whole Nordic region, a region with mixed
non-physician and physician based HEMS/EMS systems.
2.4 Summary of Study Rationale
Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving
intervention. A recent meta-analysis of >15.000 patients reported a variation in the PHETI
success rate with different methods used and provider background. 20 A Danish PHAAM
study demonstrated a 99,7% anaesthesiologist ETI success rate with a 7,9% complication
rate.6 The authors concluded the study was from a homogenous Danish system limiting the
ability to generalise the findings to other systems with different staffing, caseload or case mix.
Even though the EMS structure is rather similar in the Nordic countries, there are
considerable differences both between and within the countries. The inter- and intra-national
differences may affect the PHAAM success rate and complications, and thereby patient
safety.
3. STUDY AIM
We aim to provide prospective multicentre data on the pre-hospital intubation success rate and
complications in the Nordic countries. Additionally we will compare the PHAAM procedure
for different subgroups of patients, regions and EMS organisations.
3.1 Primary Endpoint
 Primary endpoints is overall PHETI success rate
Vi måste diskutera primär endpoint för subgruppsjämförelserna. Kan t ex vara “overall
PHETI success rate” alternativt “successful PHETI ≤ 2 attempts and no complications” eller
“PHETI success without difficult intubation or complications”
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Definitions: According to Sollid et al 26 successful intubation is defined as the endotracheal
tube verified in the trachea. An intubation attempt is defined as attempted laryngoscopy with
the intent to intubate. Failed PHETI is defined as cases where it is not possible to perform
PHETI. Difficult PHETI is defined in accordance with both the template by Sollid et al 26 and
the latest version of the “Practice guidelines for management of the difficult airway” by the
American Society of Anaesthesiologists as more than one attempt needed to successfully
perform tracheal intubation.27 PHAAM-related complications is vomiting, aspiration of
gastric content or blood to the lungs, accidental intubation of the oesophagus or right main
stem bronchus, dental trauma and/or during ETI onset of hypoxia (oxygen saturation < 90%),
hypotension (systolic blood pressure < 90 mmHg) and/or bradycardia (pulse <60 beats per
minutes).26
3.2 Secondary Endpoint
 PHETI success on 1st attempt and no complications
 PHETI success rate on 1st, 2nd, 3rd and >3rd attempt
 Number of PHETI attempts
 Failed PHETI
 Difficult PHETI
 Complications related to PHAAM.
 PHAAM-related complications linked to the number of PHETI attempts needed to
secure a patent airway
 Cormac-Lehane 28
 The incidence and type of use of airway back-up devices
 Pre-hospital mortality
4. STUDY PLAN
4.1 Study Design
A Nordic multicentre descriptive PHAAM study, in which airway management core data will
be prospectively collected according the template by Sollid et al.26 12 Nordic (Sweden,
Norway, Denmark and Finland) HEMS/EMS bases will be included in the study. The EMS
providers will fill in a registration form containing the PHAAM core data recommended by
Sollid et al (4.3). The registration form will be tested for readability and user friendliness on
ten randomly chosen pre-hospital critical care physicians and nurses before the study start.
Prior to the initiation of data registration, all pre-hospital providers will be introduced to the
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registration form by e-mails and staff meetings. Patients will be included in the study May 01
2015 to November 01 2016.
4.2 Study Setting
12 Nordic HEMS/EMS bases (Sweden, Norway, Denmark and Finland) will be included in
the study. The Nordic regions in the study utilize a one or two-tiered EMS system.12 The first
tier consists of road ambulances staffed by a nurse with additional EMS training and a driver
with basic emergency training. The second tier consists of prehospital critical care teams
staffed with non-physicians (paramedics or nurse anaesthetists / EMS nurse) or physicians
(experienced anaesthesiologists).Error! Bookmark not defined. 29 Most of the
anaesthesiology trained nurses and physicians work part-time in hospitals and are experienced
in intubation procedures. The prehospital critical care team routinely utilizes pulse-oximetry
and end-tidal capnography for monitoring the ventilation. For non-cardiac arrests drug
facilitated or rapid-sequence intubation protocols are regularly used.
4.3 Study Population
All patients who undergo PHETI by the providers from the 12 Nordic EMS regions and
HEMS/RCC critical care teams are included in the study. The decision to perform PHAAM is
based on the discretion of prehospital provider.
The Danish PHAAM critical care team study with 10 critical care teams in central Denmark
included 636 patients during 1,5 years-> 636/1,5=424 patients/year-> 424/10= 42
patients/CCT/year
The European AIRPORT study has included 2335 patients/21 CCT=111 patients/CCT
January 2012 to march 2013.
Based on the calculations above, we anticipate to include 42x1,5 years x 12 bases= 756
patients during 1,5 years
4.3.1 Inclusion Criteria
1.
Need for pre-hospital intubation
The indications for performing PHAAM as categorised by Sollid et al. are 1)
decreased level of consciousness 2) hypoxemia 3) ineffective ventilation 4)
existing airway obstruction 5) impending airway obstruction 6) combative or
uncooperative patient 7) relief of pain or distress 8) cardiopulmonary arrest 9)
other.
2.
All ages
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4.3.2 Exclusion Criteria
1.
No exclusion criteria
4.4 Data Collection
The pre-hospital provider fill in a registration form containing the PHAAM core data
recommended by Sollid et al.26 Data collected include:
1. Background – Including provider education (paramedic, reg. nurse, nurse specialist, nurse
anaesthetist, non physician not anaesthesiology, physician non anaesthesiologist, physician
anaesthesiologist) and experience (years as reg. nurse, nurse spec, physician, anaesthesiologist
and EMS/HEMS provider)
2. Alarm data
3. Patient data
4. Patient category (blunt trauma, penetrating trauma, non trauma
CA/asthma/COPD/ENT/Stroke/other)
5. First registered vital signs
6. PHAAM indication (decreased level of consciousness, hypoxemia, ineffective ventilation,
existing airway obstruction, impending airway obstruction, combative or uncooperative
patient, relief of pain or distress, cardiopulmonary arrest, other)
7. Airway evaluation
8. “Plan A” for airway management (BMV, LMA, ETI, other)
9. Best Cormack-Lehane score
10. Number of airway management attempts
11. Number of airway management devices used
12. Final method used for airway management (BMV, LMA, ETI, other)
13. Post intervention ventilation mode
14. Drugs during airway management
15. Complications related to airway management
16. First post-intervention vital signs
17. Vital signs upon arrival at the emergency department
18. Prehospital outcome
19. PHAAM not performed (incl reason)
4.5 Data extraction and analysis
Data will be extracted from the registration form containing all the core data recommended by
Sollid et al. If the data is inconclusive or missing, source data verification will be done
through the ambulance medical records.
The data according to 4.4 will be transferred to a SPSS database for statistical analysis.
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4.6 Adverse Drug Reactions and Medical Device Complications
This is a non-intervention observational trial. The Adverse Drug Reactions (ADR) and
Medical Device Complications is to bee reported to the European and national regulatory
authorities according to the legislation in the participating country.
5. STATISTICAL CONSIDERATION
This is a prospective observational study, for which reason power calculation is waived. IBM
SPSS Statistics version 21 will be used for the statistical analysis.
5.1 Subgroup analysis
 Subgroup analysis of the PHAAM endpoints (3.1-2) per patient category (4.3.4) listed
above.
-
-
Subgroup analysis will be performed on patients with traumatic brain injury.
Traumatic brain injury is defined as “Trauma” + GCS <9.
A separate analysis of trauma patients with hospital diagnosis records, autopsy or
national database stating a diagnosis of intracranial haemorrhage (ICD S06.1S06.91, I61, I62).
Subgroup analysis will be performed on patients with cardiac arrest etc.
 Subgroup analysis of the PHAAM endpoints (3.1-2) per PHAAM indication (4.3.6)
 Subgroup analysis of the PHAAM endpoints (3.1-2) per airway evaluation (4.3.7)
 Subgroup analysis of the PHAAM endpoints (3.1-2) per pharmaceutical method
(4.3.14), i.e. without the assistance of drugs, as drug-assisted without muscle relaxant
or as RSI.
 Subgroup analysis of the PHAAM endpoints (3.1-2) per airway management method
(4.3.8 and 4.3.12)
 Subgroup analysis of the PHAAM endpoints (3.1-2) for airway management outside
or inside HEMS and/or EMS cabin
 Subgroup analysis of the PHAAM endpoints (3.1-2) per HEMS/EMS base/country
(4.3.1)
 Subgroup analysis of the PHAAM endpoints (3.1-2) per provider education and
experience (4.4.1)
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6. ETHICAL CONSIDERATION
The study will be submitted for approval of the Ethical Review Board (ERB) in participating
countries. Data handling and record keeping will be done in compliance with the regulatory
requirements in the Nordic countries.
7. PRINCIPAL INVESTIGATOR AND STUDY ORGANISATION
PI
Professor Hans Morten Lossius, MD, PhD
Head of Research, Norwegian Air Ambulance Foundation.
Sc/Inv.
Sweden
Denmark
Norway
Finland
Monitor
The study will be monitored and managed on a daily basis by Mikael Gellerfors
as part of his Karolinska Institute PhD program.
D Gryth, C Svensén, M Gellerfors
L Rognås, S Mikkelsen
HM Lossius, A Krüger (?), E Fevang (?)
Tbd
Additional members of the steering committee and investigators
will be appointed.
8. TIMEFRAME AND ECONOMY
8.1 Planning
Deadline
HEMS/EMS bases question/inclusion
Draft study protocol ready
MG/HML HEMS/EMS bases visits
Study protocol adjustments according to bases
ERB approval
First patient in
Last patient in
Deadline
01-12-2014
15-12-2014
15-02-2015
01-03-2015
15-04-2015
01-05-2015
01-11-2016
Data management
Publication submission
01-12-2016
31-01-2017
8.2 Economy
An application for study grant through the Norwegian Air Ambulance Foundation will be
filed.
9. OTHER INFORMATION
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9.1 Data Handling and Recordkeeping
Data handling and record keeping will be done in compliance with the national and European
regulatory requirements.
9.2 Publication Policy
The results from the trial will be submitted for publication in national and international
journals.
9.3 Abbreviations
ADR
BMI
ED
EMS
ERB
GCS
HEMS
ISS
PHETI
PHAAM
RRC
Adverse Drug Reaction
Body Mass Index
Emergency Department
Emergency Medical Services
Ethical Review Board
Glasgow Coma Scale
Helicopter Emergency Medical Services
Injury Severity Score
Pre-Hospital Endotracheal Intubation
Pre-Hospital Advanced Airway Management
Rapid Response Car
10. REFERENCES
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4
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Von Vopelius-Feldt J, Benger JR: Prehospital anaesthesia by a physician and paramedic critical care team in
Southwest England. Eur J Emerg Med 2012, 00. No 00. DOI: 10.1097/MEJ.0b013e32835b08b7.
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injured patients. Injury 2013, 44(5):618–623.
Perkins ZB, Wittenberg MD, Nevin D, Lockey DJ, O’Brien B: The relationship between head injury severity
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intubation. Prehosp Emerg Care 2010, 14(2):278–282.
11
Krüger AJ1, Lossius HM, Mikkelsen S, Kurola J, Castrén M, Skogvoll E. Pre-hospital critical care by
anaesthesiologist-staffed pre-hospital services in Scandinavia: a prospective population-based study. Acta
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Langhelle A, Lossius HM, Silfvast T, Bjornsson HM, Lippert FK, Ersson A, Soreide E. International EMS
Systems: the Nordic countries. Resuscitation 2004; 61: 9–21
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entrapped patients. Acta Anaesthesiol Scand 2009;52:1257-1261
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Adnet F, Jouriles NJ, Le Toumelin P, Hennequin B, Taillandier C, Rayeh F, Couvreur J, Nougiere B, Nadiras
P, Ladka A, et al: Survey of out-of-hospital emergency intubations in the French prehospital medical system: a
multicenter study. Ann Emerg Med 1998, 32(4):454–460.
17
Chesters A, Keefe N, Mauger J, Lockey D: Prehospital anaesthesia performed in a rural and suburban air
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journal: EMJ 2013, 00:1–4.
18
Nakstad AR, Heimdal HJ, Strand T, Sandberg M: Incidence of desaturation during prehospital rapid sequence
intubation in a physician-based helicopter emergency service. Am J Emerg Med 2011, 29(6):639–644.
19
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review of one year on the London Helicopter Emergency Medical Service. J Trauma 2008, 64(2):487–492.
20
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comprehensive 20meta-analysis of the intubation success rates of EMS providers. Critical care (London,
England) 2012, 16(1):R24.
21
Breckwoldt J, Klemstein S, Brunne B, Schnitzer L, Arntz HR, Mochmann HC: Expertise in prehospital
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Resuscitation 2012, 83(4):434–439.
22
Helm M, Hossfeld B, Schafer S, Hoitz J, Lampl L: Factors influencing emergency intubation in the prehospital setting–a multicentre study in the German Helicopter Emergency Medical Service. Br J Anaesth 2006,
96(1):67–71.
23
Helm M, Kremers G, Lampl L, Hossfeld B: Incidence of transient hypoxia during pre-hospital rapid sequence
intubation by anaesthesiologists. Acta Anaesthesiol Scand 2013, 57(2):199–205.
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Lockey DJ, Healey B, Crewdson K, Chalk G, Weaver AE, Davies GE. Advanced airway management is
necessary in prehospital trauma patients.Br J Anaesth. 2014 Dec 23. pii: aeu412. [Epub ahead of print]
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26
Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital
advanced airway management. Scand J Trauma Resusc Emerg Med 2009, 17:58.
27
Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA,
Benumof JL, Berry FA, et al: Practice guidelines for management of the difficult airway: an updated report by
the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology
2013, 118(2):251–270.
28
Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia 1984; 39: 1105–11
29
Krüger AJ, Skogvoll E, Castren M, Kurola J, Lossius HM. Scandinavian pre-hospital physician-manned
Emergency Medical Services – same concept across borders? Resuscitation 2010; 81: 427-433.
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