CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 900 enrolled
Drug / intervention
Lung protective strategy ventilationprocedure
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/NCT01441791
NCT01441791N/ACompleted

Protective Ventilation During General Anesthesia for Open Abdominal Surgery - a Randomized Controlled Trial

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·interventional·Posted Sep 28, 2011·Updated Dec 9, 2014

In Brief

A clinical study evaluating Lung protective strategy ventilation for Postoperative Respiratory Complications. Completed, enrolled 900 participants across 30 sites in 10 countries.

Detailed Summary

The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Chile, Croatia, Germany, Italy, Netherlands, Spain, United Kingdom, United States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.8 years ago

Interventions

Lung protective strategy ventilationprocedure

Patients are randomized and intra-operatively ventilated with a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers)