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

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Completed
• CT.gov ID: NCT02148692
• Collaborator: European Society of Anaesthesiology (Other)
• Enrollment: 2,013
• Locations: 24
• Arms: 2
• Actual Duration (Months): 46
• Patients Per Site: 83.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity; Surgery; General Anesthesia	Procedure: Higher PEEP; Procedure: Lower PEEP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2013 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Higher PEEP PEEP of 12 cmH2O or higher and lung recruitment maneuvers	Procedure: Higher PEEP
Active Comparator: Lower PEEP PEEP of 4 cmH2O without lung recruitment maneuvers	Procedure: Lower PEEP

Outcome Measures

Primary Outcome Measures

1. Postoperative pulmonary complications [Five postoperative days]

2. Hospital-free days at day 90 [90 postoperative days]

3. Mortality at day 90 [90 postoperative days]

4. Postoperative extra-pulmonary complications [Five postoperative days]

5. Postoperative wound healing [Five postoperative days]

Secondary Outcome Measures

1. 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)

2. Need for postoperative ventilatory support [Five postoperative days]

   invasive or non-invasive ventilation

3. Unexpected need for ICU admission or ICU readmission within 30 days [Five postoperative days]

4. Need for hospital readmission within 30 days [30 postoperative days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital, Harvard University	Boston	Massachusetts	United States
2	Mayo Clinic	Rochester	Minnesota	United States
3	Medical University	Vienna		Austria
4	AZ Sint Jan Brugge-Oostende AV	Brugge		Belgium
5	Ghent University Hospital	Ghent		Belgium
6	ABC Medical School	Sao Paulo		Brazil
7	Saint Michael's Hospital, University of Toronto	Toronto		Canada
8	Saint Eloi University Hospital	Montpellier		France
9	Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus	Dresden	Saxony	Germany	01307
10	University of Aachen	Aachen		Germany
11	University of Bonn	Bonn		Germany
12	University of Leipzig	Leipzig		Germany
13	Semmelweis Egyetem	Budapest		Hungary
14	Tel Aviv Medical Center	Tel Aviv		Israel
15	University of Foggia	Foggia		Italy
16	University of Genoa	Genoa		Italy
17	Città della Salute e della Scienza	Turin		Italy
18	University of Insubria	Varese		Italy
19	Academic Medical Center, University of Amsterdam	Amsterdam		Netherlands
20	Hospital Universitari Germans Trias I Pujol	Barcelona		Spain
21	University Hospital Uppsala	Uppsala		Sweden
22	Hôpitaux Universitaires de Genève	Geneva		Switzerland
23	University of Istanbul	Istanbul		Turkey
24	Sheffield Teaching Hospitals	Sheffield		United Kingdom

Sponsors and Collaborators

• Technische Universität Dresden
• European Society of Anaesthesiology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technische Universität Dresden
• ClinicalTrials.gov Identifier: NCT02148692
• Other Study ID Numbers: ANE-PROBESE
• First Posted: May 28, 2014
• Last Update Posted: Jan 3, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of Jan 3, 2019