Abstract
BackgroundPostoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.Methods/designThe PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.DiscussionTo our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.Trial registrationClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
Highlights
Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients
To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative positive end-expiratory pressure (PEEP) during protective low tidal volume ventilation on PPCs in obese patients
The aim of the PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) trial is to compare the effects of two intraoperative mechanical ventilation strategies on PPCs, extrapulmonary postoperative complications (PEPCs), and length of hospital stay, as well as intraoperative lung function and hemodynamics, in surgical patients with body mass index (BMI) ≥35 kg/m2
Summary
Mechanical ventilation has the potential to aggravate or even initiate lung injury. Respiratory strategies that increase the pressure of the airways during induction of anesthesia, such as the application of noninvasive ventilation [44], use of PEEP with [45] or without RMs [46], or a combination of all of these [47], seem to be useful for improving the respiratory function of obese patients in the pre- and intraoperative periods [48] Their effects seem to be short-lived in the postoperative period [49, 50]. In-hospital length of stay and mortality increase with the number of single pulmonary AEs in the postoperative period [1] For this reason, in the PROBESE trial, we opted for a binary collapsed composite of single adverse pulmonary events as a primary endpoint, despite the fact that single events may differ in terms of severity.
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