Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients
- Conditions
- Morbid ObesitySurgeryGeneral Anesthesia
- Interventions
- Procedure: Higher PEEPProcedure: Lower PEEP
- Registration Number
- NCT02148692
- Lead Sponsor
- Technische Universität Dresden
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2013
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Higher PEEP Higher PEEP PEEP of 12 cmH2O or higher and lung recruitment maneuvers Lower PEEP Lower PEEP PEEP of 4 cmH2O without lung recruitment maneuvers
- Primary Outcome Measures
Name Time Method Postoperative pulmonary complications Five postoperative days Hospital-free days at day 90 90 postoperative days Mortality at day 90 90 postoperative days Postoperative extra-pulmonary complications Five postoperative days Postoperative wound healing Five postoperative days
- Secondary Outcome Measures
Name Time Method Intra-operative complications Surgery period complications related to the ventilation strategy (for example: de-saturation, defined as SpO2 ≤ 92%, for \> 1 min; hypotension during recruitment maneuvers, as defined by systolic arterial pressure \< 90 mmHg for \> 2 min)
Need for postoperative ventilatory support Five postoperative days invasive or non-invasive ventilation
Unexpected need for ICU admission or ICU readmission within 30 days Five postoperative days Need for hospital readmission within 30 days 30 postoperative days
Trial Locations
- Locations (24)
University of Genoa
🇮🇹Genoa, Italy
Città della Salute e della Scienza
🇮🇹Turin, Italy
Ghent University Hospital
🇧🇪Ghent, Belgium
Saint Michael's Hospital, University of Toronto
🇨🇦Toronto, Canada
University of Aachen
🇩🇪Aachen, Germany
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
🇩🇪Dresden, Saxony, Germany
Medical University
🇦🇹Vienna, Austria
ABC Medical School
🇧🇷Sao Paulo, Brazil
University of Leipzig
🇩🇪Leipzig, Germany
University of Istanbul
🇹🇷Istanbul, Turkey
Saint Eloi University Hospital
🇫🇷Montpellier, France
University of Insubria
🇮🇹Varese, Italy
Hôpitaux Universitaires de Genève
🇨🇭Geneva, Switzerland
Massachusetts General Hospital, Harvard University
🇺🇸Boston, Massachusetts, United States
University of Foggia
🇮🇹Foggia, Italy
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Sheffield Teaching Hospitals
🇬🇧Sheffield, United Kingdom
University of Bonn
🇩🇪Bonn, Germany
Hospital Universitari Germans Trias I Pujol
🇪🇸Barcelona, Spain
Academic Medical Center, University of Amsterdam
🇳🇱Amsterdam, Netherlands
University Hospital Uppsala
🇸🇪Uppsala, Sweden
AZ Sint Jan Brugge-Oostende AV
🇧🇪Brugge, Belgium