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

Primary Purpose

Morbid Obesity, Surgery, General Anesthesia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Higher PEEP
Lower PEEP
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital, Harvard University
  • Mayo Clinic
  • Medical University
  • AZ Sint Jan Brugge-Oostende AV
  • Ghent University Hospital
  • ABC Medical School
  • Saint Michael's Hospital, University of Toronto
  • Saint Eloi University Hospital
  • Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
  • University of Aachen
  • University of Bonn
  • University of Leipzig
  • Semmelweis Egyetem
  • Tel Aviv Medical Center
  • University of Foggia
  • University of Genoa
  • Città della Salute e della Scienza
  • University of Insubria
  • Academic Medical Center, University of Amsterdam
  • Hospital Universitari Germans Trias I Pujol
  • University Hospital Uppsala
  • Hôpitaux Universitaires de Genève
  • University of Istanbul
  • Sheffield Teaching Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Higher PEEP

Lower PEEP

Arm Description

PEEP of 12 cmH2O or higher and lung recruitment maneuvers

PEEP of 4 cmH2O without lung recruitment maneuvers

Outcomes

Primary Outcome Measures

Postoperative pulmonary complications
Hospital-free days at day 90
Mortality at day 90
Postoperative extra-pulmonary complications
Postoperative wound healing

Secondary Outcome Measures

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)
Need for postoperative ventilatory support
invasive or non-invasive ventilation
Unexpected need for ICU admission or ICU readmission within 30 days
Need for hospital readmission within 30 days

Full Information

First Posted
May 23, 2014
Last Updated
January 2, 2019
Sponsor
Technische Universität Dresden
Collaborators
European Society of Anaesthesiology
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1. Study Identification

Unique Protocol Identification Number
NCT02148692
Brief Title
Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients
Acronym
PROBESE
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
European Society of Anaesthesiology

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Surgery, General Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2013 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Higher PEEP
Arm Type
Experimental
Arm Description
PEEP of 12 cmH2O or higher and lung recruitment maneuvers
Arm Title
Lower PEEP
Arm Type
Active Comparator
Arm Description
PEEP of 4 cmH2O without lung recruitment maneuvers
Intervention Type
Procedure
Intervention Name(s)
Higher PEEP
Intervention Type
Procedure
Intervention Name(s)
Lower PEEP
Primary Outcome Measure Information:
Title
Postoperative pulmonary complications
Time Frame
Five postoperative days
Title
Hospital-free days at day 90
Time Frame
90 postoperative days
Title
Mortality at day 90
Time Frame
90 postoperative days
Title
Postoperative extra-pulmonary complications
Time Frame
Five postoperative days
Title
Postoperative wound healing
Time Frame
Five postoperative days
Secondary Outcome Measure Information:
Title
Intra-operative complications
Description
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)
Time Frame
Surgery period
Title
Need for postoperative ventilatory support
Description
invasive or non-invasive ventilation
Time Frame
Five postoperative days
Title
Unexpected need for ICU admission or ICU readmission within 30 days
Time Frame
Five postoperative days
Title
Need for hospital readmission within 30 days
Time Frame
30 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts General Hospital, Harvard University
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Medical University
City
Vienna
Country
Austria
Facility Name
AZ Sint Jan Brugge-Oostende AV
City
Brugge
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium
Facility Name
ABC Medical School
City
Sao Paulo
Country
Brazil
Facility Name
Saint Michael's Hospital, University of Toronto
City
Toronto
Country
Canada
Facility Name
Saint Eloi University Hospital
City
Montpellier
Country
France
Facility Name
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
University of Aachen
City
Aachen
Country
Germany
Facility Name
University of Bonn
City
Bonn
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
Facility Name
University of Foggia
City
Foggia
Country
Italy
Facility Name
University of Genoa
City
Genoa
Country
Italy
Facility Name
Città della Salute e della Scienza
City
Turin
Country
Italy
Facility Name
University of Insubria
City
Varese
Country
Italy
Facility Name
Academic Medical Center, University of Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Barcelona
Country
Spain
Facility Name
University Hospital Uppsala
City
Uppsala
Country
Sweden
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland
Facility Name
University of Istanbul
City
Istanbul
Country
Turkey
Facility Name
Sheffield Teaching Hospitals
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36093886
Citation
Ellenberger C, Pelosi P, de Abreu MG, Wrigge H, Diaper J, Hagerman A, Adam Y, Schultz MJ, Licker M; PROBESE investigators, of the PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology and Intensive Care (ESAIC). Distribution of ventilation and oxygenation in surgical obese patients ventilated with high versus low positive end-expiratory pressure: A substudy of a randomised controlled trial. Eur J Anaesthesiol. 2022 Nov 1;39(11):875-884. doi: 10.1097/EJA.0000000000001741. Epub 2022 Sep 12.
Results Reference
derived
PubMed Identifier
31157366
Citation
Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505. Erratum In: JAMA. 2019 Nov 12;322(18):1829-1830.
Results Reference
derived
PubMed Identifier
28454590
Citation
Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Muller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0. Erratum In: Trials. 2017 Jun 1;18(1):247.
Results Reference
derived

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

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