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Effect of intensive versus moderate alveolar recruitment strategies added to lung-protective ventilation on postoperative pulmonary complications: a randomized clinical trial [with consumer summary]
Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, de Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JOC Jr, Jatene FB, Gomes Galas FRB, Amato MBP
JAMA 2017 Apr 11;317(14):1422-1432
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

IMPORTANCE: Perioperative lung-protective ventilation has been recommended to reduce pulmonary complications after cardiac surgery. The protective role of a small tidal volume (VT) has been established, whereas the added protection afforded by alveolar recruiting strategies remains controversial. OBJECTIVE: To determine whether an intensive alveolar recruitment strategy could reduce postoperative pulmonary complications, when added to a protective ventilation with small VT. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients with hypoxemia after cardiac surgery at a single ICU in Brazil (December 2011 to 2014). INTERVENTIONS: Intensive recruitment strategy (n = 157) or moderate recruitment strategy (n = 163) plus protective ventilation with small VT. MAIN OUTCOMES AND MEASURES: Severity of postoperative pulmonary complications computed until hospital discharge, analyzed with a common odds ratio (OR) to detect ordinal shift in distribution of pulmonary complication severity score (0-to-5 scale, 0, no complications; 5, death). Prespecified secondary outcomes were length of stay in the ICU and hospital, incidence of barotrauma, and hospital mortality. RESULTS: All 320 patients (median age 62 years; IQR 56 to 69 years; 125 women (39%)) completed the trial. The intensive recruitment strategy group had a mean 1.8 (95% CI 1.7 to 2.0) and a median 1.7 (IQR 1.0 to 2.0) pulmonary complications score versus 2.1 (95% CI 2.0 to 2.3) and 2.0 (IQR 1.5 to 3.0) for the moderate strategy group. Overall, the distribution of primary outcome scores shifted consistently in favor of the intensive strategy, with a common OR for lower scores of 1.86 (95% CI 1.22 to 2.83; p = 0.003). The mean hospital stay for the moderate group was 12.4 days versus 10.9 days in the intensive group (absolute difference -1.5 days; 95% CI -3.1 to -0.3; p = 0.04). The mean ICU stay for the moderate group was 4.8 days versus 3.8 days for the intensive group (absolute difference -1.0 days; 95% CI -1.6 to -0.2; p = 0.01). Hospital mortality (2.5% in the intensive group versus 4.9% in the moderate group; absolute difference -2.4%, 95% CI -7.1% to 2.2%) and barotrauma incidence (0% in the intensive group versus 0.6% in the moderate group; absolute difference -0.6%; 95% CI -1.8% to 0.6%; p = 0.51) did not differ significantly between groups. CONCLUSIONS AND RELEVANCE: Among patients with hypoxemia after cardiac surgery, the use of an intensive versus a moderate alveolar recruitment strategy resulted in less severe pulmonary complications while in the hospital. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01502332.

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