Running Head: SAFE EARLY EXTUBATION How Early Extubation Can Safely Be Achieved in Cardiac Surgery: A Review of Literature. Rachel Anderson University of Virginia School Of Nursing GNUR 6315 Clinical Decision Making in Acute and Specialty Care-Seminar II 1 Running Head: SAFE EARLY EXTUBATION 2 Abstract Early extuabation has been identified as a safe way to improve patient outcomes and possibly reduce health care costs. A review of the literature was done to answer the question, “How can early and effective extubation be achieved in the cardiac surgery population”. It was found through this literature review that short acting anesthesia medication, dexmedetomidine, thoracic epidural analgesia, post extubation positive pressure ventilation, and aggressive rewarming were all important factors. Nursing implications across all stages of the surgical process are discussed. Keywords: Fast track extubation, early extubation, cardiac surgery Running Head: SAFE EARLY EXTUBATION Introduction Cardiac surgery has undergone almost a complete transformation since its start in 1893 (Cohn, 2008). These revolutions have been a result of anesthesia advancements, improved utilization of cardiopulmonary bypass (CPB), and improved post-operative management. As this surgery continues to evolve, ways to improve patient outcomes and length of stay remain high priorities, however in the past decade, while the number of cardiac surgery case has steadily increased, there has been little reduction in the patient’s days to discharge (http://www.sts.org/sites/default/files/documents/pdf/ndb2010/3rdHarvestExecutiveSummary201 0.pdf, 2011). In an effort to minimize rising health care (http://www.cms.gov/nationalhealthexpenddata/01_overview.asp?, 2011), hospitals seek to find safe strategies to reduce expenditures for both the patients and their organizations by reducing length of stay in both the intensive care unit and hospital. In a Cochrane review, (Hawkes, Dhileepan, and Foxcroft, 2003) it was investigated if early extubation in cardiac surgery patients could reduce not only the length of stay, but also patient mortality rates. It was found that there was neither a positive nor negative effect on mortality rates with early extubation, however there was a reduction in intensive care unit and hospital length of stay. The review went on the suggest investigation was needed to establish the safety and efficacy of early extubation in this patient population. The Society of Thoracic Surgeons, an international, multi-disciplinary organization, was formed to improve surgical outcomes in patients whose surgery is within the chest (http://www.sts.org/about-sts, 2011). As a sub-group of this organization, the Virginia Cardiac Surgery Quality Initiative identified early extubation as one possible way to improve outcomes in its 2008-2009 model. In a review of centers that had achieved early extubation, as defined as being within four to eight hours after surgery, several facilitating factors were identified. The 3 Running Head: SAFE EARLY EXTUBATION 4 predominant reasons were: use of less sedation and shorter-acting muscle relaxants; Bispectral Index montoring (BIS) as part of a cardiac anesthesia protocol; allowed extubation of patients on Intra-Aortic Balloon Pump; use of moderate hypothermia intraoperatively with more aggressive re-warming postoperatively; using the same standing orders for all surgeons; promote understanding by tracking extubation times for all anesthesiologists and discussing results at quarterly meetings (http://www.sts.org/sites/default/files/documents/pdf/newsletters/NDB/DBnewsMarch08.pdf, 2011). Purpose It has been seen in the literature that early extubation may be one way to reduce health care costs through shorted length of hospital and intensive care stays, and it has been identified by one organization that there are specific factors in how early extubation can be achieved. Therefore the purpose of this paper is to review the literature in an effort to answer the suggested research need proposed by the Cochrane review of, “How can early and effective extubation be achieved in the cardiac surgery population.” Factors explored will include, but not be limited to the suggested reason as described by the Virginia Cardiac Surgery Quality Initiative’s investigation. How these findings can be utilized in nursing practice will then be identified. Review Methods A systematic review of the literature was composed using PubMed and CINAHL. Terms used were as follows: cardiac surgery early extubation; cardiac surgery fast track extubation; and open heart surgery early extubation. Only patient populations eighteen years and older were included. Surgery types included were isolated coronary artery bypass grafting (CABG) done on and off cardiopulmonary bypass (CPB), isolated aortic and/or mitral valves, and combination Running Head: SAFE EARLY EXTUBATION CABG with valve. Dates were limited to 2001 to 2011. Search engines included articles from all languages and were equipped to include dissertations when available. Early extubation for the search was defined as less than 10 hours. An additional manual review of cardiac surgery text book was done to search for early extubation achievability. Significant studies are included in Table 1 and corresponding levels of evidence were assigned to each study to determine their strength in practice. Literature Findings Extubation Criteria In discussing how early extubation can be achieved, it must first be discussed what determines if a patient is extubatable. In order for the endotracheal tube to be removed, the majority of cardiac surgery text books have agreed the following must be present: adequately intact neurologic status to maintain an airway, stable hemodynamics, adequately rewarmed, absence of malignant lethal arrhythmias, adequate respiratory effort, and absence of mediastinal bleeding in excessive amounts (Andrea et al., 2009; Hardin and Kaplow, 2009; Ciulli, Thorpe, Ciulli, and Franco, 2003). In reviewing the literature, two lower levels of evidence studies were found that evaluated the reasons for not extubating in less than six hours (Sato et al., 2009) (Akhtar and Hamid, 2009). Both studies showed the recommendations from the text were being observed, as it was found that those requiring large doses of medication for hemodynamic support, those neurologically compromised, and those with high mediastinal chest tube output all remained intubated longer. 5 Running Head: SAFE EARLY EXTUBATION It is important to recognize when evaluating the literature, that while most centers share these parameters for extubation, their individual definitions of each criterion vary center to center, and therefore adds variability to what makes a patient extubatable. Effects of Cardiopulmonary Bypass The dramatic and sometimes devastating effects of the CPB to the patient’s renal, neurologic, and hematologic function as well as hemodynamic status (Henke and Eigsti, 2003) can affect the patient’s stability post-operatively. Despite these well documented facts, the literature is divided on the CPB’s role in achieving safe early extubation. In Cohn’s Cardiac surgery in the adult (2008), multivariate study findings were discussed which concluded that the duration of CPB was in direct correlation to length of postoperative intubation time. An addition study found intubation times were shorter in those with shorter CPB times (Georghiou et al, 2006). In contrast, in comparing CABGs that did use CPB to those who did not, one study found equal effects exhibited on the respiratory system between the two groups (Roosens et al, 2002). In investigating intra-operative variables on extubation times, another study supported this by finding no significant correlation in CPB time and extubation time (Walthall and Ray, 2002). In discussing the reasons for the differing findings, one reason may be that in light of the known effects of CPB, several manufacturers have changed the mechanisms in their machines to lessen the negative effects (Gravlee, Davis, Stammers, and Ungerleider, 2008) and there is not standardization across centers in terms of which kind of machines are used. Additionally, the length of the tubing has been shown to impact the effects of the CPB, and therefore some centers have chosen to use shorter tubing. A final factor may be that different centers prime their pumps with different fluids that vary from blood products to crystalloids. The use of blood intra- 6 Running Head: SAFE EARLY EXTUBATION operative has been proven to have negative post-operative outcomes (Vamvakas and Blajchman, 2010) therefore this variable may also be a reason for the conflicting findings. Anesthesia and Post-operative medications To preform cardiac surgery, general anesthesia is used for pain control, muscle relaxation, and amnesia effect. A combination of inhaled, intravenous, and sometimes, epidural agents, are used. Anesthesia medication duration, mechanism of action, and side effects all have effects on the patient that last well into the post-operative period, and therefore are evaluated here to determine their effects of time to extubation. Dexmedetomidine In 1999 the Federal Drug Administration approved Dexmedetomidine for short term use (<24 hours) and in recent years it has gained increased use in the cardiac surgery population (http://www.precedex.com, 2011). As an alpha-2 agonist, this drug has applications as premedication, an anesthetic adjunct for general and regional anesthesia, and as a postoperative sedative and analgesic. Effects are similar to benzodiazepines, but with fewer side effects, such as heavy sedation. In researching the effects of using Dexmedetomidine to decrease intubation times postoperatively, several studies have been done. One study showed shorter times to extubation and a secondary finding discovered that lower doses of neuromuscular blockade agents and fewer administrations of narcotics were need (Afanador et al., 2010). This study also showed that in the Dexmedetomidine group, there was a reduction in the systemic inflammatory response syndrome that often in cardiac surgery patients. This is significant because this syndrome lowers the systemic vascular resistance and therefore the patient’s blood pressure. Persistent hypotention 7 Running Head: SAFE EARLY EXTUBATION prolongs the patient’s time to extubation, thus Dexmedetomidine may be instrumental in decreased intubation times through this pathway as well. When discussing early extubation as a way to decease hospital cost, it becomes important to recognize the higher expense often associated with Dexmedetomidine, which is mainly due to its Federal Drug Administration approval only being within the last eleven years. Two studies compared its administration to a variety of different agents, and both studies showed Dexmedetomidine as having a higher cost than traditional anesthesia agents (Barletta, Miedema, Wiseman, Heiser, and McAllen, 2009; http://www.eimjm.com/Vol6-No2/Vol6-No2-B1.htm, 2011). Therefore a multi-variable analysis of effect on cost related to administration and hospital length of stay must be evaluated before choosing this agent for the sole purpose of decrease intubation times in an attempt to reduce costs. Traditional Anesthesia agents When administering intra-operative medications for sedation and pain control, the traditional agents are usually some combination of midazolam, propofol, sufentanil, remifentanil, and/or fentanyl. These drugs can also be combined with Dexmedetomidine both intra-operatively and post-operatively to enhance effects and decrease dosages required. When comparing use of sufentanil versus remifentanil versus fentanyl, what sets them apart in their use, is the pharmacodynamics of the drugs and their half-lives. Each is selected for surgery based on its predominate benefit in use. Fentanyl works longer than the others and is a cheaper drug. sufentanil is five to ten times more potent fentanyl and has a half-life that is shorter than fentanyl but longer than remifentanil. It is this superior short life of three to ten minutes that usually is the reason for selecting reminfentanil as an anesthetic agent. One randomized control study compared all three agents for: time to tracheal extubation, time to intensive care unit 8 Running Head: SAFE EARLY EXTUBATION discharge, time to hospital discharge, postoperative pain, and cost. It was found that were was no significant difference among the drugs in any of these outcomes (Engoren, Luther, FennBuderer, 2001). In another randomized control study, fentanyl was compared to sufentanil for its effects on time taken for extubation, hemodynamic stability, analgesia requirements and incidence of awareness. The results were that those in the sufentanil group extubated faster, however it is significant to note that in the sufentanil group there was one incidence of awareness during surgery (Deshpande, Mohite, and Kamdi, 2009). Propofol is often chosen because of its short half-life as a sedating agent and its ability to be given in a continuous drip that can be continued in the cardiac surgery intensive care unit. Midazolam, as a longer lasting benzodiazapine, it is often only given intra- and post-operatively as intravenous boluses. In comparing the two through a study seeking to find if any intraoperative variables that could have effected extubation times after CABG, it was seen that there was no significant difference in those using propfol versus the midazolam (Walthall and Ray, 2002). Similar findings were present in a study that compared the use of fentanyl paired with midazolam versus propofol (Sato et al., 2009). In addition to sedating agents, neuromuscular blocking agents are used to paralyze the patient once sedation is achieved. As with the sedating agents, in choosing a paralytic, half-life becomes important to achieve early extubation. In a randomized control trial it was found that using rocuronium should be preferred over pancuronium because there were faster exubation times with less residual muscular blockade in the post-operative recovery unit (Thomas, Smith, and Strike, 2003). This finding is largely attributed to the shorter half of rocuronium. Murphy et al’s (2002) randomized control study’s findings were similar, and suggested also that rocuronium be used instead of pancuronium when early extubation is the goal. However in both of these 9 Running Head: SAFE EARLY EXTUBATION studies it was found that though extubation times were shortened, there was no decrease in hospital or intensive care unit length of stay. There have been studies that have successfully used panuronium in their fast track programs; however they have used the reversal agent neostigmine to clear the pancuronium post-operatively (Najafi, 2008) Two separate studies were conducted that found their fast track programs were successful in reducing extubation times and the anesthesia medications used were considered for their influence. The first study’s intervention group used oral lorazapm as premedication (Reis, Mota, Ponce, Costa-Pereira, and Guerreiro, 2002), while the other study used clonidine in their intervention group (Ender, et al., 2008). For induction, both studies used propofol, but differed in their use of fentanyl (Reis et al., 2002) versus sufentanil (Ender, et al, 2008). The paralytic used was not stated by Reis et al (2002), however Ender et al (2008) identified using rocuronium in their fast track group. With maintenance of anesthesia, isoflurance was alone being used (Reis et al., 2002) in the first study and a continuous infusion of remifentanil, propofol and sevoflurance were utilized in the second study (Ender et al., 2008). Post-operatively, pain was managed by a morphine PCA in the Reis et al. study (2002) in contrast to the bolus doses of piritramide and paracetamol used by Ender et al, (2008). In reviewing the agents that are used intra-operatively for cardiac surgery, it is seen that for both narcotics and neuromuscular blocking agents, drugs that have a shorter half-life should be selected because not only do they shorten the time to extubation, but this can be achieved without serious consequences to other patient outcomes in most cases. Thoracic Epidural Analgesia For the cardiac surgery patient, effective pain relief can be difficult to achieve while striving to maintain adequate level of consciousness for the patient to maintain effective 10 Running Head: SAFE EARLY EXTUBATION oxygenation and ventilation. For these reasons, epidurals are beneficial in surgery patients because of their quick effects and greater pain relief at lower opioid analgesic doses. Two separate studies were preformed that looked at how using thoracic epidural analgesia immediately before surgery and continuing into the post-operative period would affect times to extubation. The first found no superior outcomes with extubation in either the traditional intravenous opiod group or the in thoracic epidural group (Hemmerling et al., 2005), however it is of note that this was a level IV evidence study. Caputo et al (2011) however found in their randomized control trail, that using a thoracic epidural in conjunction with conventional general anesthesia led to not only earlier exutbation times, but also a reduction in arrhythmias and hospital length of stay. Ventilation In fast track extubation programs, the parameters of readiness to extubate are not different from those of traditional cardiac surgery ventilator weaning. The measurements of maximal inspiratory effort, forced respiratory capacity, adequate arterial blood gases and patient ability to protect their airway remain the same. It is, instead the path to meet these goals that is different in the fast track programs. The use of CPB has been well studied as having dramatic effects throughout the body in cardiac surgery patients. To determine how to offset these effects on the lungs and subsequently reduce time to extubation, studies have explored different theories. In a randomized control trial, Eren et al (2003) sought to determine if giving N-acetylcysteine intravenously would counter the effects of the CPB. It was found that while there was oxygenation improvements, there was no effect on outcomes or differences in extubation times. 11 Running Head: SAFE EARLY EXTUBATION The proinflammatory response of the body to the CPB and subsequent transient gas exchange abnormalities has been the rationale for research addressing how different approaches to post-operative ventilation could effect extubation times. One study was conducted to see if using nasal continuous positive airway pressure (CPAP) routinely immediately after extubation was more effective at keeping the patient from reintubation. The result was that it in fact decreased pneumonia and re-intubation rates, as well readmission to higher levels of care (Zarbock et al., 2009). In a study of one programs implemented fast track program, it was seen that use of bi-level positive airway pressure (BIPAP) for all patients for one hour after extubation contributed to their success rates of safely decreasing intubation times (Ender et al., 2008). For use in fast track extubation patients, these findings may be helpful as a way to bridge or support patients who may still have some transient gas exchange abnormalities from the CPB while at the same time removing the breathing tube. Other factors Two separate studies (Walthall and Ray, 2002; Georghiou et al., 2006) looked retrospectively to determine what variables could have effected time to extubation after CABG, and both studies found that the number of vessels bypassed did not effect extubation times. In determining the effect of advanced age (as defined as those older than seventy) on early extubation, one study (Kogan et al., 2008) found that age alone should not preclude placing a patient into a fast track extubation plan. However it was seen through this study that those over the age of eighty were more likely to have at least one postoperative complication. Another study acknowledge that younger patients were more likely to extubate quicker and also that men were had shorter intubation times (Georghiou et al., 2006). 12 Running Head: SAFE EARLY EXTUBATION Rewarming the patient more aggressively when coming off CPB with subsequent higher presenting body temperatures in the recovery intensive care unit has also been attributed to earlier extubation times (Reis et al, 2002; Ender et al. 2008). As discussed earlier rewarming patients to normothermia is one prerequisite of extubation. The reason rewarming is important is hypothermia can lead to complications of malignant lethal arrhythmias, increase systemic vascular resistance with heightened myocardial oxygen demand, shivering with amplified metabolic demand, and impairment of the clotting cascade which can lead to increased mediastinal drainage. A device called a Bispectral index monitor is often used intraoperatively to determine the patient’s level of awareness and sedation during surgery. As stated by the Virginia Cardiac Surgery Quality Initiative, it has been hypothesized that using this device in the postoperative intensive care unit may decrease time to extubation. From this literature review only one study was found, which showed that there was no difference in time to extubation with the use of the Bispectral index monitor (Anderson, Henry, Hunt, and Ad, 2010) Outcomes of fast track programs Three studies compared the safety and abilities of their programs to reduce intubation times. All three studies showed that their programs were successful in decreasing time to extubation. Camp et al. (2009) and Ender et al. (2008) found reduction in hospital length of stay. Ender et al. (2008) also reporting reduced mortality rates and Camp et al. (2009) found reduced morbidities, however Reis et al (2002) found that neither morbidity, mortality or hospital length of stay were reduced through their fast track program. 13 Running Head: SAFE EARLY EXTUBATION Nursing implications As more hospitals move to reduce time to extubation through fast track programs, it is important for nurses to be aware of the current literature in order to support an evidence based practice. There was no literature found that discusses the impact these programs could have on decreasing delays or rescheduling of cardiac surgeries as a result of shortening intensive care unit and hospital length of stay. However, realizing how fast track programs effect work flow of the operating room, intensive care unit and step down floors is vital to make accommodating staffing plans. In the preoperative setting, understanding the early extubation program is necessary for patient education. This includes providing realistic expectations and information on the process if the patient has the potential for not being able to extubate early. Also, understanding how such pre-operative interventions as oral benzodiazepines and thoracic epidurals can affect things other than pain and anxiety control, allows the nurse to teach the patient on their importance. For the intensive care nurse, determining if a patient is an appropriate candidate for fast track extubation should include several factors, including their intra-operative drugs. Therefore, it should be the post-operative nurse’s practice to know which medications were given during surgery. If longer acting neuromuscular blocking agents were used, such reversal agents as neostigmine can be used to facilitate readiness to wean from the ventilator. When selecting a method of pain and anxiety management, understanding the role dexmedetomidine should be clearly understood by the recovering nurse so that advocating for adjunct or transitional drug therapy can be done when appropriate. If short acting pain medications such as remifentanail were used during surgery, the recovering nurse should recognize that pain medication may be required earlier. 14 Running Head: SAFE EARLY EXTUBATION When deciding if a patient is appropriate for early extubation after surgery, the nurse should recognize that patients should not be excluded from fast track extubation because of CPB use. It should be recognized that those with long run times on the CPB have experienced longer times to extubation. Patient age should also not be a primary excluding factor for early extubation, however the nurse’s expectation should be that those who are younger will extubate sooner. Most studies excluded those with pulmonary comorbidities from their studies. For this reason, it cannot be concluded if those with lung disease could be safely allocated for early extubation. The use of positive pressure applied post-extubation has been successful in fast track programs as a routine measure. If used in a fast-track program, nursing should understand the pathophysololgy for its application ranges beyond those with lung disease or inadequate arterial blood gases. For those who may be questionable in their readiness to extubate, BIPAP/CPAP may be used as a safe, successful bridge. Aggressive rewarming should start in the operating room and be continued into the intensive care unit. Rewarming is important to prevent postoperative complication of arrhythmias, bleeding, and hemodynamic compromise. As part of the early extubation pathway, using methods and devices to regain normothermia should be high priorities. Use of multiple disciplines has been shown to be a successful practice when implementing programs because of the depth and breadth of knowledge added to the discussion. Though not seen as an intervention in the reviewed studies, to successfully implement an early weaning program, a multi-disciplinary approach should be used and include physicians, anesthesiologists, nurses, and respiratory therapists. To establish clear standards, ventilator weaning protocols should be utilized that are easy to understand with defined, measurable 15 Running Head: SAFE EARLY EXTUBATION 16 criteria. If involved in the building team for a new fast track extubation program, the nurse must understand the multiple factors that contribute to extubation times and their relationship to one another. While the literature is not certain if earlier extubation translates to lower morbidity, mortality, or length of stay, for the cardiac surgery nurse early extubation can result in a lighter work load. As the patient comes off of the ventilator sooner, arterial lines and pulmonary catheters may be removed earlier and facilities ease of movement out of bed. Aggressive aims at pain reduction have been attributed to reduced intubation times (Hawkes, Dhileepan, and Foxcroft, 2003). Programs that implement such interventions as thoracic epidural analgesia to meet early extubation goals, reduces the need for frequent dosing of pain medication, subsequently reducing nurse work load. For hospitals that are structures to support a post op day 0 transfers to step down or intermediate care units, earlier extubation times allow more transfers out to these units and reduces instances where the admitting nurse would be doubled with a fresh post-operative cases. In hospitals that do not support early transfer from the intensive care unit, if an admitting nurse needs to have a second patient, keeping an extubated patient could reduce that nurses work load. Summary Early extuabation has been identified as a safe way to improve patient outcomes and possibly reduce health care costs. In answering the question, “How can early and effective extubation be achieved in the cardiac surgery population” it was found through this literature review that short acting anesthesia medication, dexmedetomidine, thoracic epidural analgesia, post extubation positive pressure ventilation, and aggressive rewarming were all important factors . Nursing implications across all stages of the surgical process can be seen through this Running Head: SAFE EARLY EXTUBATION literature review. As patient educators, fast track program forming team members, strategy implementation participants, and guides to patient care flow, nurses are invaluable members for early extubations to be achieved. Further research on the impact on nursing care workloads and the reduction of operating room delays requires further research and as studies evaluate the effects of early extubation on reducing health care costs, nursing retention and increased cardiac surgery operating room cases should be considered. 17 Running Head: SAFE EARLY EXTUBATION 18 Source Populatio n Type of Study/Level of Evidence Problem/Purpose Findings Strengths/Weaknesses Camp, Stamou, Stiegel, Reames, Skipper, Madjarov, ... Lobdell, (2009) Isolated CABG’s and valves. Combinati on CABG and Valve. N=All 2211 patients operated on between 2002 and 2006 were included. Not clear. “Uncompl icated, elective heart surgery” N=97 nonDexmedet omidine N=103 Dexmedet omidine Retrospectiv e Cohort study Evaluate implementation of quality program to decrease intubation times (to <6hrs). Primary: Early extubation times increased after quality program started. Secondary: Early extubation population experienced lower rates of sepsis, PNA, readmissions, and readmissions to ICU. Also reduced days in hospital and in ICU. No blinding used in data review To determine effect of using Dexmedetomidine intra-op on time to tracheal extubation No blinding used in data review No disclosures made No power analysis Elective CABG. N=20 patients Prospective, Randomized Control Trial. Doubleblinded. Placebocontrolled study. Primary: Shorter times to extubation in Dexmedetomidine group. Secondary: Fewer/lower doses of NMBA and narcotics used with Dexmedetomidine. Reducion of SIRS in Dexmedetomidine group Group receiving N-acetylcysteine had a less increase in A-a gradient, but had no affects. No difference in intubation times. Afanador, Marulanda, Torres, Marín, Vidal & Silva. (2010) Eren, Cakir, Oruc, Kaya, & Erdinc. (2003) IIB Retrospectiv e cohort study IIB IB Evaluate if giving N-acetylcysteine IV pre-op will counter the effects of CPB and reduce pulmonary complications post-op. Logistic regression analysis and propensity score adjustment used to compensate for preoperative confounders. Attempts made to match confounders between groups. Statistical analysis of pvalue used. Small sample size without power analysis. No disclosure statement made Confounders excluded from study. Strong statistical analysis:Manning/Whitne y U-test, ANOVA, posthoc Tukey’s B and Tamhane’s T test used in addition to p-values. Running Head: SAFE EARLY EXTUBATION 19 Source ICU Pop. Type of Study/Level of Evidence Problem/Purpose Findings Strengths/Weaknesses Zarbock, Mueller, Netzer, Gabriel, Feindt, & Kindgen-Milles (2009) Elective CABG or heart valve replace ment. N=500. Randomized Control Trial To determine the efficacy of prophylactic nasal Continuous Positive Airway Pressure after extubation when compared with conventional, no application. Several hours of nasal Continuous Positive Airway Pressure following cardiac surgery improved PaO2, reduced pneumonia and reintubation rates, as well as readmission to intensive or intermediate care units. No power analysis done. Walthall & Ray (2002) Isolated CABG. N=100 Retrospectiv e Cohort Investigate whether any intraoperative variables had a significant effect on extubation time after CABG. No significant extubation time differences in those on propfol vs midazolam. Number of vessels required to be bypassed, use of IMA graft, and CPB time were not show to have an effect of extubation times, as was hypothesized by authors. IB IIB Authors included a literature review of studies similar to theirs and made their statement findings based on their study as well as the other studies. Took into account confounders, and separated into 4 groups to counteract, as well as excluded other confounders. Statistical analysis used: post hoc power analysis (t test) with the Scheffe test, Chi Square test, and Bonferroni correction. No Power analysis done with small sample size. Anesthesia medications not stated in study. Double blinded. Patients randomly selected. Same surgeon and anesthesiologist used, and therefore standardization of procedures and medications. Multi-variate simultaneous linear regression used in addition to 1-sample Kolomogorov-Smirnov test. Also P value utilized. Running Head: SAFE EARLY EXTUBATION 20 Recognized study’s findings were contradictory of other studies. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Deshpande, Mohite Isolated & Kamdi. (2011) valves and simple repair of congenit al heart disease. N=100. Type of Study/Level of Evidence Randomized, prospective, double blinded control trial. IB 21 Problem/Purpose Findings Strengths/Weaknesses Compare fentanyl versus Sufentanil when used as a part of the balanced anaesthesia technique for fast track in cardiac surgery patients. Evaluated the time taken for extubation, hemodynamic stability, analgesia requirements & incidence of awareness. Time for mechanical ventilation in Sufentanil group was found to be reduced more than that in Fentanyl group. Total doses of Tramadol required in the postoperative period till next morning were similar, though those in the Sufentanil group needed dosing sooner. Sufentanil group had awareness during anaesthesia. Both sufentanil and fentanyl provide hemodynamic stability. BIS not used in Operating Room. Confounders removed before randomization. Standardization of other anesthesia medications given as well as parameters for extubation. Chi-square, t-test with p-value used. Power analysis used. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Sato, Suenaga, Koga, Matsuyama, Kawasaki & Maki (2009) Isolated on pump CABG. N=485 (all done at this center) Akhtar & Hamid (2009) Elective CABG. N=614 (all patients after excluding confounders done at this center) Type of Study/Level of Evidence Case Series IV 22 Problem/Purpose Findings Strengths/Weaknesses To determine the differences in patients who did and did not extubate in less than six hours. p-value was the only statistical analysis preformed. Because of the high success rates to early extubation (92%) more description of methods used in Operating Room and Intensive Care Unit could have been given to describe not only why those 8% did not extubate, but also why maybe the 92% did. Prospective To identify the observational causes of delayed study extubation post operatively. IIIB High rates of early extubation with standardized medication method in OR of versed/fentanyl or propofol. Those who scored low on the EuroSCORE, had more vessels to bypass, lower EFs, higher CT output, and/ or blood administration in ICU (but not OR), longer OR and CPB times had longer times to extubate. Surprisingly COPD did not effect extubation times. Patients on high dose inotropes, hemodynamically unstable, reexplored for bleeding, deep sedation, and confusion were the reason for not extubating in <6 hrs. No blinding done. Only 388 patients on the original sample size were selected for fast track, but the reason for the exclusions were not given. No statistical analysis done, including pvalue. Confounders excluded. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Najafi (2008). Isolated CABG. N=100 Type of Study/Level of Evidence Prospective Cohort study IIB Reis, Mota, Ponce, CostaPereira & Guerreiro (2002) Isolated CABG using CPB. N=323 Prospective cohort study IIB 23 Problem/Purpose Findings Strengths/Weaknesses To assess the risks and benefits of conduction the fast track method in cardiac anesthesia and to evaluate the role of continuous infusion of short acting anesthetics. Tracrium was used as a NMBA in the fast track group (vs Pancuronium in the non-fast track) and NMBA reversal was done using Neostigmine in fast track group. Fentanyl infusion was used in the fast track group both intra-op and for 12 hours post op (vs bolus PRN does in non-fast track). Fast track group came off of CPB at warmer body temperatures than the non-fast track. No blinding used. Not randomized and not stated how the patients were allocated into the fast track vs non track groups. No power analysis To compare nonfast track extubations with fast track extubations for safety. Very fast track extubation protocol may be safely implemented. Time to extubation was shortened in the fast track group. No morbidity or mortality difference between groups. One way analysis of variance or a two-way between group analysis of variance with repeat measurements over time were done inaddition to Chi square test and MannWhitney U test. Kaplan-Meier Survival curves were calculated for time to extubation and LOC in ICU and hospital stay. Findings in light of other studies/short literature review of similar studies given also. Patients randomly assigned to fast track and non-fast track group. T test and Chi square test used. The non-fast track group had a variety of different induction drugs. No power analysis done. Study conclusions stated that fast track extubation can be safely implemented as Running Head: SAFE EARLY EXTUBATION 24 a way to decrease health care cost. However, re-intubation rates and mortality rates were not given. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Hemmerling, Olivier, Choinière, Basile & Prieto. (2005) Isolated Aortic Valve Replacement N=45 Caputo, Alwair, Rogers, Pike, Cohen, Monk, . . . Angelini (2011) Off pump CABG patients N=226 Type of Study/Level of Evidence Prospective audit, pilot study IV Randomized controlled trial IB 25 Problem/Purpose Findings Strengths/Weaknesses The feasibility and hemodynamic stability of immediate extubation (in OR) after simple or combined aortic valve surgery using either thoracic epidural analgesia or opioid-based analgesia. Prospective audit is statistically weak. To evaluate the impact of thoracic epidural anesthesia on early clinical outcomes in patients undergoing offpump coronary artery bypass surgery. Immediate extubation is feasible after aortic valve surgery using either high thoracic epidural analgesia or opioid-based analgesia; both techniques maintain hemodynamic stability throughout surgery. 3 patients in the epidural group needed reexploration. Bupivacaine, 0.5% bolus given via epidural in intervention group during induction followed by infusion of 0.125% bupivacaine and 0.0003% clonidine. Addition of thoracic epidural to conventional general anesthesia accounts for a significant reduction in postoperative arrhythmias and improvement in overall quality of recovery, allowing an earlier tracheal extubation and hospital discharge Data of each recording time point were compared using a Friedman test other wise no confirming analysis was done. Power Analysis done Hazard ratios used Time-to-event curves were constructed using the Kaplan– Meier method. Binary outcomes were compared using odds ratios. Linear regression, with logarithmic transformations were used for skewed data. Not blinded, and there was no independent resolution of clinical endpoints. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Barletta, Miedema, Wiseman, Heiser & McAllen (2009). Isolated CABG and/or valve N=100 Engoren, Luther, & FennBuderer (2001). Cardiac Surgery N=90 Thomas, Smith & Strike (2003). Cardiac surgery patients reelected to be on fast track extubation plan. N=20 Type of Problem/Purpose Findings Study/Level of Evidence Retrospective To compare Dexmedetomidine cohort study postoperative resulted in lower opioid opioid requirements IIB requirements in in patients after patients who cardiac surgery received versus those dexmedetomidine receiving propofol, versus propofol but this did not after cardiac result in shorter surgery and durations of determine these mechanical effects on time to ventilation, using a extubation. fast-track model. Randomized Compare the No differences in the control trial effects of outcomes from remifentanil, fentanyl-, sufentanilIB sufentanail, and , and remifentanilfentanyl on time based cardiac to tracheal anesthetics. They all extubation, time produce similar to intensive care outcomes and have unit (ICU) similar direct discharge, time to variable costs hospital discharge, postoperative pain, and cost. Prospective Compare the In order to achieve randomized duration of action goal extubation of < double-blind of pancuronium 6 hours, unless fastcontrol trial and rocuronium in track patients have patients neuromuscular undergoing fastfunction assessed IB track hypothermic before cardiopulmonary extubation, bypass and pancuronium should cardiac surgery. not be used. 26 Strengths/Weaknesses Findings of study for extubation times were secondary, not primary purpose of the study. Matching between groups was done. T and U test was done. Power analysis done. Chi-square test done as well as well as fisher exact test. Power Analysis was done. Standardization of all other factors (ie other drugs intra-operatively and weaning standards from vent) Kruskal-Wallis test, onferroni multiple comparisons procedure was used, Chi-square or Fishers exact test was done. Power analysis done. Standardization of drugs/sedation among groups not done. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Anderson, Henry, Hunt & Ad. (2010). All cardiac surgery patients N=50 Roosens, Heerman, De Somer, Caes, Van Belleghem, & Poelaert, (2002) Elective CABG. N= 10 with extracorporeal and 13 without. Type of Study/Level of Evidence Prospective Cohort study IIB Prospective controlled study. IIB 27 Problem/Purpose Findings Strengths/Weaknesses Dose use of a BIS monitor postoperatively effect time to extubation. Chi square test used with student t test. To compare effects of cardiac surgery with and without extracorporeal circulation. BIS monitor did not facilitate earlier extubation in the stable patient after cardiac surgery Small sample size with no power analysis. Variance in staff knowledge of device with no prior training. Both extracorporeal Not clear how patients and nonwere assigned to the extracorporeal extracorporeal and patients exhibited non-extracorporeal dramatic impairment groups. of respiratory system Not randomized. mechanics, and Small sample size with therefore off pump no power analysis. CABG patients should have the Exclusion of same caution when confounders extubating as on Standardization of pump patients. NMBA’s and narcotics Repiratory as well ventilation. compromise was Statistical analysis worse during the includes power first 3 hours post-op analysis, Wilcoxon’s in both groups. signed ranks test with Bonferroni correction, and Mann-Whitney Utest for independent samples. Running Head: SAFE EARLY EXTUBATION Source ICU Pop. Ender, Borger, Scholz, Funkat, Anwar, Sommer, . . . Fassl (2008) Cardiac surgery patients (surgery type not given) N=433 (all patients in first 6 months of fast track program) Type of Study/Level of Evidence Prospective Cohort study IIB 28 Problem/Purpose Findings Strengths/Weaknesses Compare the safety and efficacy of a fast-track protocol implemented by anesthesiologists in a directadmission PACU to standard perioperative management 1:1 propensity-score matching on many variables to the historical control group. Logistic regression model used. Fisher exact test and of continuous traits with the Kolmogorov– Smirnov test used. Wilcoxon rank sum test was used if testing between matched cohorts and the Mann–Whitney U test for others. P value for significance used. Oral premedication with dipotassium clorazepate the evening before and clonidine on the day of surgery. Leipzig fast-track protocol used Anesthetic induction was performed with propofol, sufentanil and rocuronium. For maintenance of anesthesia during the pre- and postcardiopulmonary bypass period, a continuous infusion of remifentanil and sevoflurane was used. During cardiopulmonary bypass, a continuous propofol infusio also was administered. Paracetamol given right before skin closure. Aggressive warming via blanket under patient. Postoperative analgesia consisted of a bolus of piritramide and paracetamol. All patients were on BIPAP for 1 hour post extubation. Fast-track patients had significantly shorter times to No blinding used No specification for type of surgery Running Head: SAFE EARLY EXTUBATION 29 extubation, as well as postoperative lengths of stay. There was no significant difference between groups with regards to readmissions to higher levels of care or morbidity rates. Fast-track patients had a significantly lower mortality than controls. Running Head: SAFE EARLY EXTUBATION Source Georghiou, Stamler, Erez, Raanani, Vidne, & Kogan (2006) ICU Pop. Type of Problem/Purpose Findings Study/Level of Evidence Isolated Retrospective To determine if Compared coronary Cohort Study early extubation with artery could be patients bypass IIB accelerated to < 6 extubated surgery hr after arrival at within 6–10 the cardiothoracic hr, those N=545 ICU. extubated before 6 hr were younger and comprised a higher proportion of men. Crossclamp and CPB times were significantly shorter in the patients extubated in less than 6 hr. The mean number of grafts per patient was similar in both groups. The goal was achieved of extubating in less than 6 hrs. 30 Strengths/Weaknesses Student’s t test; confidence intervals with P test used. No Power analysis used. Excluded confounders. BernsteinParsonnet risk estimate done. Note: CABG=Coronary artery bypass grafting. 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