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

Completed · Not applicable

Conditions studied: Morbid Obesity, Surgery, General Anesthesia

In brief

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.

Key facts

Study ID

NCT02148692

Run by

Technische Universität Dresden

People needed

2013

Starts

2014-07-01

Expected to finish

2018-05-01

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient scheduled for open or laparoscopic surgery under general anesthesia
• Intermediate-to-high risk for PPCs following surgery, according to the ARISCAT risk score (≥ 26)
• BMI ≥ 35 kg/m2
• Expected duration of surgery ≥ 2 h

You may not qualify if…

• Age < 18 years
• Previous lung surgery (any)
• Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician)
• History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
• Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)
• Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)
• Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days
• Pregnancy (excluded by anamneses and/or laboratory analysis)
• Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
• Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure > 40 mmHg
• Intracranial injury or tumor
• Neuromuscular disease (any)
• Need for intraoperative prone or lateral decubitus position
• Need for one-lung ventilation
• Cardiac surgery
• Neurosurgery
• Planned reintubation following surgery
• Enrolled in other interventional study or refusal of informed consent

Where it is running

• 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
• University of Bonn — Bonn, Germany
• University of Leipzig — Leipzig, Germany
• Semmelweis Egyetem — Budapest, Hungary
• Tel Aviv Medical Center — Tel Aviv, Israel
• University of Foggia — Foggia, Italy
• University of Genoa — Genoa, Italy
• Città della Salute e della Scienza — Turin, Italy
• University of Insubria — Varese, Italy
• Academic Medical Center, University of Amsterdam — Amsterdam, Netherlands
• Hospital Universitari Germans Trias I Pujol — Barcelona, Spain
• University Hospital Uppsala — Uppsala, Sweden
• Hôpitaux Universitaires de Genève — Geneva, Switzerland
• University of Istanbul — Istanbul, Turkey (Türkiye)
• Sheffield Teaching Hospitals — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.