CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,013 enrolled
Drug / intervention
Higher PEEP +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02148692
NCT02148692N/ACompleted

Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients

Technische Universität Dresden·interventional·Posted May 28, 2014·Updated Jan 3, 2019

In Brief

A clinical study evaluating Higher PEEP and Lower PEEP for Morbid Obesity and 2 related conditions. Completed, enrolled 2,013 participants across 24 sites in 16 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Brazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 28, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2018
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.1 years ago

Interventions

Higher PEEPprocedure

Lower PEEPprocedure