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Factors Affecting the Decision to Defer Endotracheal Extubation After Surgery for Congenital Heart Disease: A Prospective Observational Study

Kin, Nobuhide MD*; Weismann, Constance MD; Srivastava, Shubhika MD; Chakravarti, Sujata MD; Bodian, Carol DrPH§; Hossain, Sabera MS§; Krol, Marina PhD; Hollinger, Ingrid MD; Nguyen, Khanh MD; Mittnacht, Alexander J. C. MD

doi: 10.1213/ANE.0b013e31821cd236
Pediatric Anesthesiology: Research Reports
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SDC

BACKGROUND: Fast-tracking and early endotracheal extubation have been described in patients undergoing surgery for congenital heart disease (CHD); however, criteria for patient selection have not been validated in a prospective manner. Our goal in this study was to prospectively identify factors associated with the decision to defer endotracheal extubation in the operating room (OR).

METHODS: We performed a prospective observational study of 275 patients (median age 18 months) at the Mount Sinai Medical Center (MSMC), New York, New York, and 49 patients (median age 25 months) at the University of Tokyo Hospital (UTH), Tokyo, Japan, undergoing surgery for CHD requiring cardiopulmonary bypass. These patients were all eligible for fast-tracking, including extubation in the OR immediately after surgery, according to the respective inclusion/exclusion criteria applied at the 2 sites.

RESULTS: Eighty-nine percent of patients at the MSMC, and 65% of patients at the UTH were extubated in the OR. At the MSMC, all patients without aortic cross-clamp, and patients with simple procedures (Risk Adjustment for Congenital Heart Surgery [RACHS] score 1) were extubated in the OR. Among the remaining MSMC patients, regression analysis showed that procedure complexity was still an independent predictor for not proceeding with planned extubation in the OR. Extubation was more likely to be deferred in the RACHS score 3 surgical risk patients compared with the RACHS score 2 group (P = 0.005, odds ratio 3.8 [CI: 1.5, 9.7]). Additionally, trisomy 21 (P = 0.0003, odds ratio 9.9 [CI: 2.9, 34.5]) and age (P = 0.0015) were significant independent predictors for deferring OR extubation. We tested our findings on the patients from the UTH by developing risk categories from the MSMC data that ranked eligible patients according to the chance of OR extubation. The risk categories proved to predict endotracheal extubation in the 49 patients who had undergone surgery at the UTH relative to their overall extubation rate, despite differences in anesthetic regimen and inclusion/exclusion criteria.

CONCLUSIONS: Preoperatively known factors alone can predict the relative chances of deferring extubation after surgery for CHD. The early extubation strategies applied in the 2 centers were successful in the majority of cases.

Published ahead of print April 13, 2011 Supplemental Digital Content is available in the text.

From the *Department of Anesthesiology, University of Tokyo, Tokyo, Japan; Pediatric Cardiology, and Departments of Pediatrics, Anesthesiology, and Surgery; and §Division of Biostatistics, The Mount Sinai School of Medicine, New York, New York.

Supported by intramural departmental funding.

The authors declare no conflicts of interest.

Reprints will not be available from the authors.

Address correspondence to Alexander J. C. Mittnacht, MD, Department of Anesthesiology, The Mount Sinai School of Medicine, The Mount Sinai Hospital, Box 1010 One Gustave L. Levy Place, New York, NY 10029. Address e-mail to alexander.mittnacht@mountsinai.org.

Accepted March 21, 2011

Published ahead of print April 13, 2011

Surgery for congenital heart disease (CHD) using cardiopulmonary bypass (CPB) typically requires mechanical ventilation. Some centers attempt early endotracheal extubation as part of a fast-tracking strategy, whereas others prefer mechanical ventilation in the intensive care unit (ICU) as their routine patient management in the postoperative period. Generally, the term “early extubation” is applied when the endotracheal tube is removed within 6 to 8 hours after the surgery. However, the term has been used with extubation in the operating room (OR) and as late as 24 hours after surgery.1 Immediate extubation after CHD surgery was common practice in the early days of pediatric cardiac surgery.24 More recently, several retrospective studies have suggested that this practice can be performed safely in simple and complex surgical cases for all age groups.5,6 Although fast-tracking, including early extubation, has been described in patients undergoing surgery for CHD, criteria for patient selection have not been validated in a prospective manner.

The goal of this study was to prospectively identify factors associated with deferring extubation at the end of the procedure, when OR extubation was planned as part of a fast-tracking approach to surgery for CHD.

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METHODS

After IRB approvals were obtained, we conducted a prospective observational study of pediatric patients undergoing surgery for CHD using CPB at the Mount Sinai Medical Center (MSMC), New York, New York, and the University of Tokyo Hospital (UTH), Tokyo, Japan, between January 2006 and September 2008. Documentation of informed consent was waived by the IRB (under US 45 CFR 46.117. [c]) because this was an observational study with prospective data collection not requiring any diversion from standard of care patient management at the participating institutions. The IRBs required, however, obtaining permission from the parents for data collection and analysis. This permission was obtained for all subjects. Assent of the minors was waived for all children younger than 12 years. Written documentation of assent was not required.

The primary end point of this study was deferring extubation in the OR immediately after surgery for CHD, despite meeting preoperative entry criteria for OR extubation. The decision that a patient was eligible for early extubation, and thus to be included in the study was made and recorded before surgery, and was based on the preoperative entry criteria then in effect at the patient's institution. If consequently the decision was made to defer extubation, this was documented by the anesthesiologist before transfer to the ICU, along with the specific reasons why the decision was made. The anesthesiologist and surgeon could choose from a list of predefined conditions that are frequently encountered and seen as contraindications or reasons why extubation is deferred.

Exclusion criteria at the MSMC were age <2 weeks and >18 years, mechanical ventilation preoperatively, surgical procedure complexity assessed with the Risk Adjustment for Congenital Heart Surgery (RACHS) score7 ≥4, and thoracic organ transplantation. Patient selection criteria for early extubation differed at the UTH. In addition to the above-mentioned exclusion criteria, all patients weighing <6 kg, patients with preoperative pulmonary hypertension (PHT), and all trisomy 21 patients were considered ineligible for early extubation at the UTH. Because of this difference in the inclusion/exclusion criteria of the 2 institutions, we chose to base our primary analysis only on the patients at the MSMC, the larger group with more factors that could be studied. We used the findings among the MSMC patients to develop a scale that grouped patients in terms of increasing chances that planned OR extubation would be deferred, and then checked to see whether the scale also ranked the UTH patients.

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Perioperative Management

At the MSMC, anesthesia was induced with sevoflurane in nitrous oxide/oxygen or with IV ketamine and maintained with isoflurane or desflurane in air/oxygen throughout the procedure. Preservative-free morphine was administered into the caudal space (<5 years of age, 50–100 μg/kg), or injected intrathecally (>5 years of age, 5–10 μg/kg). Fentanyl IV was limited to 1 to 2 μg/kg during anesthesia induction. Remifentanil (0.1–0.3 μg/kg/min) was administered continuously after central line placement. In hemodynamically unstable patients, IV ketamine (50–100 μg/kg/min) was administered by continuous infusion. All patients had arterial blood pressure monitored continuously with an indwelling catheter and central venous access established before skin incision. A pediatric multiplane transesophageal echocardiography probe (Siemens Medical Solutions USA, Inc., Malvern, PA) was inserted for intraoperative hemodynamic monitoring, and to evaluate the surgical repair.

After administration of heparin 300 U/kg, the ascending aorta, inferior vena cava, and superior vena cava were cannulated and full CPB was established. At the end of the surgical procedure, after discontinuation of CPB, modified ultrafiltration (MUF) was performed in all patients. Heparin was reversed with protamine based on a protamine-titration assay.

At the UTH, IV ketamine (1.5 mg/kg) was administered in the preoperative holding area. Anesthesia was induced with IV thiopental (5 mg/kg), and maintained with sevoflurane in air/oxygen throughout the procedure. Fentanyl IV (5–6 μg/kg) was given before skin incision. All patients had arterial blood pressure monitored continuously with an indwelling catheter and central venous access established before skin incision. A pediatric multiplane transesophageal echocardiography probe (Aloka, Tokyo, Japan) was inserted for intraoperative hemodynamic monitoring, and to evaluate the surgical repair. A continuous infusion of dexmedetomidine (0.8 μg/kg/h) was started once full CPB was established and continued throughout the procedure and in the ICU. After discontinuation of CPB, MUF was performed for 15 minutes in all patients.

All patients (MSMC and UTH) included in this analysis were eligible for extubation in the OR based on the respective entry criteria. The final decision to attempt or defer extubation in the OR was made at the end of the procedure by the attending surgeon and the anesthesiologist. Extubation was deferred in patients who did not fulfill commonly accepted extubation criteria such as adequate ventilation, full reversal of neuromuscular blockade, appropriate acid-base and metabolic status, no signs of airway compromise (signs of upper airway edema on direct inspection and/or laryngoscopy), and core temperature ≥35.0°C.8 Additional criteria that were typically part of the decision-making process to exclude patients from immediate OR extubation included oxygenation inadequate for the CHD lesion, PHT after CPB and MUF (more than two-thirds systemic pressure requiring pulmonary vasodilators), and hemodynamic instability (defined as labile or unsatisfactory hemodynamic variables such as age-appropriate arterial blood pressure despite treatment, and/or significant inotropic support with an inotrope score >20 after CPB).9 Endotracheal extubation was also deferred in patients with signs of coagulopathy (defined as chest tube drainage or bleeding in the operative field) not responsive to treatment with platelet concentrates, cryoprecipitate, and/or fresh frozen plasma according to clinical judgment and point-of-care testing such as thrombelastography. Often it was a combination of the above listed factors that led the attending anesthesiologist to decide to not proceed with planned extubation.

In cases in which extubation criteria were met, residual neuromuscular blockade was reversed with neostigmine and glycopyrrolate. Once the patient was breathing spontaneously with adequate respiratory variables, the endotracheal tube was removed and oxygen administered via a nasal cannula. IV morphine was given to patients with signs of inadequate analgesia before transfer to the pediatric ICU. A continuous infusion of dexmedetomidine (0.4–0.8 μg/kg/h) was started before transfer to the ICU. Patients for whom the attending anesthesiologist and surgeon made the decision not to proceed with extubation were converted to a high-dose opioid technique and transferred to the ICU intubated.

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Statistical Methods

Practice standard at both institutions was to extubate all eligible patients in the OR. Only patients from the MSMC were considered in the primary analyses. Each potential perioperative risk factor was screened individually to look for evidence of an association with outcome, using χ2, Fisher exact, or the Cochran-Armitage test for trend, as appropriate. The following preoperative factors were tested first: age; weight; weight percentile; gender; preoperative PHT defined as pulmonary vascular resistance index >2 Wood units × m2, or systolic right-sided pressures more than half systemic as determined by preoperative cardiac catheterization or echocardiographic studies; preoperative congestive heart failure (CHF) as diagnosed by the attending pediatric cardiologist and/or the preoperative use of medications typically prescribed to relieve symptoms of CHF (diuretics, angiotensin-converting enzyme inhibitors, digoxin); trisomy 21; RACHS score; and prior open heart surgery (reoperation). Significant or near-significant independent factors were identified by a stepwise logistic regression analysis, using a P value <0.1. Once the independent preoperative factors were found, they were frozen into the next stepwise logistic regression model and additional influence of intraoperative factors was tested. The intraoperative factors considered were CPB time, aortic cross-clamp time, anesthesia length, procedure length, and inotrope use (inotrope score). Statistical significance was defined as P < 0.05.

Categories that ranked the relative chance of early extubation were developed from the MSMC data and used to test our findings on the patients who had undergone surgery at the UTH. The categories are based on the factors selected when the multiple logistic regression model was applied to preoperative factors only. Integer points were assigned to the significant factors, approximately in proportion to the corresponding coefficients in the selected model. Scores equal to the sum of the assigned points were then derived for each eligible patient in the original cohort and grouped to produce a 4-category risk rating of R1 to R4. Because the overall level of early extubation differs markedly among institutions, and different inclusion/exclusion criteria are applied, these risk ratings are not intended to provide an estimate of the absolute risk of deferring extubation, but rather an estimate of the risk relative to the average experience at the institution. The rating was then obtained for each patient in an independent cohort (UTH) and compared with their actual outcomes.

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RESULTS

Patients included in this study were between 2 weeks and 18 years of age (median MSMC: 18 months; median UTH: 25 months; Table 1). Overall, 89% (245 of 275) of the eligible patients at the MSMC, and 65% (32 of 49) of the eligible patients at the UTH were extubated in the OR. Table 2 lists the types of cases/procedures performed at each institution and the corresponding percentage of patients who were extubated in the OR.

Table 1

Table 1

Table 2

Table 2

At the MSMC, all low-risk surgical patients (RACHS score 1, n = 42), and all other children undergoing CPB without aortic cross-clamp (n = 49) were extubated successfully in the OR. These patients were ultimately assigned the lowest risk category, and were not included in the regression analysis done to identify a set of independent factors associated with deferring OR extubation. In the remaining patients, multiple logistic regression revealed that surgical risk (RACHS score) was still an independent predictor for not proceeding with planned extubation in the OR (Table 3). The chance of deferring extubation was significantly more likely in the RACHS score 3 group compared with the RACHS score 2 surgical risk patients (P = 0.005, odds ratio 3.8 [CI: 1.5, 9.7]). Of the reasons listed by the anesthesiologist as to why extubation was deferred, coagulopathy and hypoxemia were noted more frequently in the higher surgical risk RACHS score 3 group.

Table 3

Table 3

Trisomy 21 was also a strong independent predictor of OR extubation at the MSMC. Extubation of trisomy 21 patients was significantly more likely to be deferred (P = 0.0003, odds ratio 9.9 [CI: 2.9, 34.5]). Airway compromise was 8 times more likely to occur in trisomy 21 patients compared with the children without trisomy 21 (16% vs 2%, P = 0.007), and hypoxemia before extubation was listed in 24% of the trisomy 21 patients, compared with 2.5% without trisomy 21 (P < 0.0001). Additionally, trisomy 21 patients were more likely to have multiple reasons listed by the anesthesiologist why extubation was deferred. Postoperative PHT and hemodynamic instability did not differ significantly between trisomy 21 patients and the remainder of the study population (PHT 8% vs 7%, P = 1.0, hemodynamic compromise 8% vs 4%, P = 0.61, respectively). We explored the data further to see what could be discerned about the reasons why endotracheal extubation was deferred more frequently in trisomy 21 patients. CHF, preoperative PHT, and low weight were more common in trisomy 21 patients. However, when the regression analysis was repeated on patients without trisomy 21, none of these factors emerged as significantly associated with OR extubation.

Age was also a significant independent factor associated with delayed extubation. When the association of age with extubation was explored in the univariate analyses, it was evident that there was no simple linear association with OR extubation. When ages were combined into 5 groups (<2, 2–6, 6–12, 12–24, and >24 months), the association of age with early extubation was statistically significant (P = 0.0005). Because the majority of patients in the >24 months group were extubated in the OR and the chance of deferring extubation did not increase significantly above that age, the OR extubation rate in each of the younger age groups was compared with the >24 months group. Very young patients (<2 months) and patients in the 6- to 12-month age group had the highest risks of deferred extubation (odds ratio 7.3 [CI: 1.2, 44.5] and odds ratio 9.9 [CI: 2.7, 37.3], respectively) compared with the children >2 years of age. There was no clear evidence that some association between the various age groups and other factors tested could explain this pattern of risk. In particular, there was no association between the diagnoses, specific procedures, or surgical risk (RACHS score) and the age groups. The only reason for deferring OR extubation listed by the anesthesiologist for which there was a statistically significant difference among the 5 age groups was “hemodynamic compromise,” with a 20% occurrence in children younger than 2 months and approximately 1.6% for the age group 2 to 6 months as well as older than 24 months. The 6- to 12-month age group had the highest occurrence of “PHT,” “airway obstruction,” and “coagulopathy.”

The factors we considered significance levels among the 275 MSMC patients included in the univariate analyses, and the results of the multivariate analysis applied to the 184 patients with RACHS scores of 2 or 3 and surgery with aortic cross-clamp time are shown in Table 3. The remaining preoperative factors that were associated with deferring extubation in the OR when considered in univariate analyses did not contribute significant independent information.

We looked further at factors that might have been expected to be important. When preoperative PHT was the only factor considered, it was significantly associated with deferring extubation among the entire group of 275 patients, and also among the subgroup of 184 patients who were entered in the multivariate analysis. Among the patients who were entered in the multivariate analysis, preoperative PHT was present in 6 of the 33 patients (18.2%) in whom endotracheal extubation was deferred and only 7 of the 151 children (4.6%) who were extubated in the OR (P = 0.01). Additionally, endotracheal extubation was less likely in small patients (low weight), and patients with longer CPB, procedure, and aortic cross-clamp time. However, none of the above listed factors including preoperative PHT retained their significance, once RACHS score, age, and trisomy 21 were accounted for.

The reasons given by the anesthesiologists for deferring extubation are listed for each institution in Table 4. Significant PHT after the discontinuation of CPB and after MUF had been completed (independent of preoperative PHT) was the most common cause for deferring OR extubation, followed by hypoxemia, coagulopathy, and hemodynamic instability (for definition see above).

Table 4

Table 4

Based on the findings from the MSMC patient population, relevant independent predictors were assigned points approximately proportional to their influence in the multiple regression analysis, as shown in Table 5. A higher risk category is associated with an increased risk of deferring endotracheal extubation relative to the overall level of extubation (89% at the MSMC, 65% at the UTH) (Table 6).

Table 5

Table 5

Table 6

Table 6

Two children at the MSMC required immediate reintubation in the OR for unexpected airway obstruction/edema, and one patient was reintubated soon after transfer to the ICU for hypoventilation/hypercapnia (PaCO2 of 84 mm Hg). None of the patients at the UTH required reintubation after OR extubation. Continuous positive airway pressure was applied via nasal continuous positive airway pressure mask in infants with decreased respiratory effort, and/or poor aeration on the initial chest radiograph.

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DISCUSSION

Fast-tracking, which includes early extubation typically within a few hours after surgery and in selected patients even in the OR, is not common practice in pediatric cardiac surgery. Support that fast-tracking including early extubation can be done safely even in young children and complex surgical cases comes mostly from case series and retrospective analyses.6,10,11 To our knowledge, this is the first prospective study aiming to identify factors that predict the risk of deferring OR extubation, when extubation in the OR is planned as part of a fast-tracking strategy in children undergoing surgery for CHD. The main finding is that the relative chance of deferring endotracheal extubation at the end of the procedure can be predicted reliably with preoperatively known factors. These independent predictors are surgical risk score (RACHS), surgical technique with or without aortic cross-clamping, patient's age, and trisomy 21.

Although trisomy 21 does not exclude patients from OR extubation, it has been shown that this diagnosis is frequently associated with increased perioperative morbidity, including airway compromise after surgery.1214 This was confirmed by our analysis, in which patients with trisomy 21 had a higher incidence of airway compromise and hypoxemia after surgery for CHD. Even though CHF and preoperative PHT were seen more frequently in trisomy 21 patients, further analysis indicated that these preoperative factors did not explain the significant association of trisomy 21 with deferring extubation.

Younger age has been consistently associated with prolonged mechanical ventilation after CHD surgery.15,16 Often, it is the preference of the anesthesiologist, surgeon, intensivist, or institutional policy not to extubate children after surgery for CHD younger than a certain age. This is despite numerous publications of successful early extubation strategies in all age groups, including neonates.11 Our finding that there was not a linear relationship between age and OR extubation could not be explained by a predominance of certain procedures or high-risk patients in specific age groups. Beyond the age of 2 years, however, age had very little impact on the likelihood of OR extubation.

Interestingly, none of the intraoperative factors, including CPB time, added any independent information that would help predict extubation. In many retrospective analyses published, including one from our institution,5 CPB time was associated with extubation after surgery for CHD.17,18 In this prospective study, however, CPB time was surprisingly not associated with outcome. It seems that the surgical risk classification (RACHS) “captures” other known risk factors typically associated with delayed endotracheal extubation, including CPB time and aortic cross-clamp time, so that they did not add any additional independent information once RACHS had been accounted for. Obviously, less-complex, lower-risk surgery (lower RACHS scores) typically requires less time spent on CPB, and surgery that can be performed without arresting the heart (no aortic cross-clamping) preserves cardiac function and hemodynamic stability after CPB, which helps to explain why all of those patients could be extubated in the OR at the MSMC.

PHT has frequently been cited as a risk factor preventing early extubation in children undergoing surgery for CHD.1,13 In a retrospective study of 102 children undergoing surgery for CHD, preoperative PHT was one of the main reasons listed why early endotracheal extubation was deferred.6 When evaluating preoperative PHT by itself in our analysis, there was a significant association with deferring extubation. However, once the other factors were identified in the stepwise logistic regression, preoperative PHT did not add significantly more independent information. We found that preoperative PHT rarely occurs alone and is typically accompanied by other factors, which also increase the risk of delaying endotracheal extubation. This might have obscured its potential effect. Interestingly, however, PHT after the surgical repair was the reason that was most frequently cited by the anesthesiologist for deferring extubation in our patient population. PHT does not have to be a contraindication for early endotracheal extubation. In a study by Vida et al.,14 the majority of children with preoperative PHT who underwent surgical repair of a ventricular septal defect were extubated in the OR or within 6 hours of ICU arrival. However, the definition of PHT as a mean pulmonary artery pressure >25 mm Hg19 is often not adequate to describe the various conditions that are associated with an increased pulmonary artery pressure in patients with CHD. Often, the relationship of systemic to right ventricular pressure, pulmonary vascular resistance, and pulmonary vascular reactivity are more important in determining operability and outcome, including the ability to extubate patients after surgery.20

The decision to include a patient in a fast-tracking protocol (entry criteria) will differ among institutions, and typically includes the practitioner's preferences such as age, procedure type, and preexisting conditions. For the purpose of this study, we did not attempt to challenge those practices, but rather examine whether, once a patient qualifies for a fast-tracking approach, not to proceed with one of the components of fast-tracking, namely, early extubation, can be predicted. Not attempting extubation in the OR is typically based on the practitioner's decision that the patient does not fulfill certain extubation criteria. At the time the decision was made to defer endotracheal extubation, the exact reasons were documented at both institutions. The study, however, was not designed to associate specific factors with specific decisions. In our proposed risk scale, a higher risk category does not imply that a particular patient should be excluded from endotracheal extubation, but rather predicts an increased risk that extubation will be deferred based on a higher incidence of the factors listed in Table 4.

We also did not examine factors associated with extubation failure in this study. In our series, the removal of the endotracheal tube was successful in the majority of patients once the decision was made to attempt OR extubation. This confirms that the extubation criteria used in this study can be applied safely to patients undergoing surgery for CHD. A study with the goal to explore whether existing extubation criteria could be challenged or expanded would have required us to divert from our institutional standard of care approach, and attempt extubation in almost all of our patients including those who were clearly at risk of failing such an approach. This was not considered ethical or safe.

We conducted a prospective study; however, we were not able to randomize patients because of surgeon's request to attempt extubation in all eligible patients at the end of the procedure. Also, patient selection criteria for early extubation differed at the 2 institutions. Trisomy 21 patients for example are not considered for early extubation at the UTH. For that reason, patients from the UTH were not included in the analysis to identify risk factors. The way our risk categories are defined, only the combination that includes trisomy 21 patients can have enough points to add up to the highest risk group (R-4). However, the difference in institutional extubation practice with different inclusion/exclusion criteria can be considered a strength of this study. Never is the anesthetic/surgical technique identical among institutions, and often specific subjective concerns preclude certain patients from an early extubation strategy. Our risk categories are an initial nonrigorous attempt to find whether a simple classification scheme could be developed. The fact that our risk groups were able to rank the chances for early extubation in patients from different patient populations with different anesthetic technique suggests that our findings can be transferred to other institutions and help to identify candidates suitable for a fast-tracking approach. Additionally, there was evidence in our data of considerable overlap among the various factors considered, but our sample size was not large enough to establish significant interactions in their effects.

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CONCLUSIONS

In this prospective observational study, preoperatively known factors such as procedure complexity (RACHS score), surgical technique with or without aortic cross-clamping, trisomy 21, and patient age can predict patients in whom extubation is deferred after surgery for CHD. The early extubation strategies applied in the 2 centers were successful in the majority of cases.

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DISCLOSURES

Name: Nobuhide Kin, MD.

Contribution: This author helped design the study, conduct the study, analyze the data, and write the manuscript.

Attestation: Nobuhide Kin has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Constance Weismann, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Constance Weismann has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Shubhika Srivastava, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Shubhika Srivastava has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Sujata Chakravarti, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Sujata Chakravarti has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Carol Bodian, DrPH.

Contribution: This author helped design the study, analyze the data, and write the manuscript.

Attestation: Carol Bodian has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Sabera Hossain, MS

Contribution: This author helped design the study and analyze the data.

Attestation: Sabera Hossain has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Marina Krol, PhD.

Contribution: This author helped conduct the study.

Attestation: Marina Krol has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Ingrid Hollinger, MD.

Contribution: This author helped design the study, conduct the study, and write the manuscript.

Attestation: Ingrid Hollinger has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Khanh Nguyen, MD

Contribution: This author helped design the study and conduct the study.

Attestation: Khanh Nguyen has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

Name: Alexander J. C. Mittnacht, MD

Contribution: This author helped design the study, conduct the study, analyze the data, and write the manuscript.

Attestation: Alexander J. C. Mittnacht has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.

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