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

NCT02148692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2013

Last updated 2019-01-03

No results posted yet for this study

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.

Conditions

  • Morbid Obesity
  • Surgery
  • General Anesthesia

Interventions

PROCEDURE

Higher PEEP

PROCEDURE

Lower PEEP

Sponsors & Collaborators

  • European Society of Anaesthesiology

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-02-28
Completion
2018-05-31

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148692 on ClinicalTrials.gov