Postoperative respiratory failure, particularly after surgery under general anesthesia, adds to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (PPCs), especially in obese patients. While anesthesiologists tend to use PEEP higher than in non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of PEEP with recruitment maneuvers could compromise intra-operative hemodynamics. The investigators aim to compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs. We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for PPC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,013
Massachusetts General Hospital, Harvard University
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Medical University
Vienna, Austria
AZ Sint Jan Brugge-Oostende AV
Bruges, Belgium
Ghent University Hospital
Ghent, Belgium
ABC Medical School
São Paulo, Brazil
Saint Michael's Hospital, University of Toronto
Toronto, Canada
Saint Eloi University Hospital
Montpellier, France
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
Dresden, Saxony, Germany
University of Aachen
Aachen, Germany
...and 14 more locations
Postoperative pulmonary complications
Time frame: Five postoperative days
Hospital-free days at day 90
Time frame: 90 postoperative days
Mortality at day 90
Time frame: 90 postoperative days
Postoperative extra-pulmonary complications
Time frame: Five postoperative days
Postoperative wound healing
Time frame: Five postoperative days
Intra-operative complications
complications related to the ventilation strategy (for example: de-saturation, defined as SpO2 ≤ 92%, for \> 1 min; hypotension during recruitment maneuvers, as defined by systolic arterial pressure \< 90 mmHg for \> 2 min)
Time frame: Surgery period
Need for postoperative ventilatory support
invasive or non-invasive ventilation
Time frame: Five postoperative days
Unexpected need for ICU admission or ICU readmission within 30 days
Time frame: Five postoperative days
Need for hospital readmission within 30 days
Time frame: 30 postoperative days
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