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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02148692
Acronym
PROBESE
Enrollment
2013
Registered
2014-05-28
Start date
2014-07-31
Completion date
2018-05-31
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Morbid Obesity, Surgery

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.

Interventions

PROCEDUREHigher PEEP
PROCEDURELower PEEP

Sponsors

European Society of Anaesthesiology
CollaboratorOTHER
Technische Universität Dresden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Postoperative wound healingFive postoperative days
Postoperative pulmonary complicationsFive postoperative days
Hospital-free days at day 9090 postoperative days
Mortality at day 9090 postoperative days
Postoperative extra-pulmonary complicationsFive postoperative days

Secondary

MeasureTime frameDescription
Need for postoperative ventilatory supportFive postoperative daysinvasive or non-invasive ventilation
Unexpected need for ICU admission or ICU readmission within 30 daysFive postoperative days
Need for hospital readmission within 30 days30 postoperative days
Intra-operative complicationsSurgery periodcomplications 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)

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026