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

Surgery Clinical Trial

— PROBESE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148692
• Other study ID #: ANE-PROBESE
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: May 2018

Study information

• Verified date: January 2019
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2013
• Est. completion date: May 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Morbid Obesity
• Obesity, Morbid
• Surgery

Intervention

Procedure:
• Higher PEEP

• Lower PEEP

Locations

Country	Name	City	State
Austria	Medical University	Vienna
Belgium	AZ Sint Jan Brugge-Oostende AV	Brugge
Belgium	Ghent University Hospital	Ghent
Brazil	ABC Medical School	Sao Paulo
Canada	Saint Michael's Hospital, University of Toronto	Toronto
France	Saint Eloi University Hospital	Montpellier
Germany	University of Aachen	Aachen
Germany	University of Bonn	Bonn
Germany	Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus	Dresden	Saxony
Germany	University of Leipzig	Leipzig
Hungary	Semmelweis Egyetem	Budapest
Israel	Tel Aviv Medical Center	Tel Aviv
Italy	University of Foggia	Foggia
Italy	University of Genoa	Genoa
Italy	Città della Salute e della Scienza	Turin
Italy	University of Insubria	Varese
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam
Spain	Hospital Universitari Germans Trias I Pujol	Barcelona
Sweden	University Hospital Uppsala	Uppsala
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Turkey	University of Istanbul	Istanbul
United Kingdom	Sheffield Teaching Hospitals	Sheffield
United States	Massachusetts General Hospital, Harvard University	Boston	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	European Society of Anaesthesiology

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pulmonary complications		Five postoperative days
Primary	Hospital-free days at day 90		90 postoperative days
Primary	Mortality at day 90		90 postoperative days
Primary	Postoperative extra-pulmonary complications		Five postoperative days
Primary	Postoperative wound healing		Five postoperative days
Secondary	Intra-operative complications	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)	Surgery period
Secondary	Need for postoperative ventilatory support	invasive or non-invasive ventilation	Five postoperative days
Secondary	Unexpected need for ICU admission or ICU readmission within 30 days		Five postoperative days
Secondary	Need for hospital readmission within 30 days		30 postoperative days