Morbid ObesityPROBESENCT02148692
Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients
A study testing Higher PEEP and Lower PEEP in people with Morbid Obesity and Surgery, run by Technische Universität Dresden at 24 sites in 16 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Surgery, General Anesthesia
- What is being tested?
- Higher PEEP and Lower PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,013 participants
- Where
- 24 sitesin 16 countries
- Study dates
- Jul 2014to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
24 sites in 16 countries.
24 sites in 16 countries
Germany4 sites
University of Aachen
Aachen
University of Bonn
Bonn
Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
Dresden, Saxony, 01307
University of Leipzig
Leipzig
Italy4 sites
University of Foggia
Foggia
University of Genoa
Genoa
Città della Salute e della Scienza
Turin
University of Insubria
Varese
United States2 sites
Massachusetts General Hospital, Harvard University
Boston, Massachusetts
Mayo Clinic
Rochester, Minnesota
Belgium2 sites
AZ Sint Jan Brugge-Oostende AV
Bruges
Ghent University Hospital
Ghent
Netherlands1 site
Academic Medical Center, University of Amsterdam
Amsterdam
About this study
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.
- Conditions
- Morbid Obesity, Surgery, General Anesthesia
- Being tested
- Higher PEEP, Lower PEEP
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher PEEPProcedure or surgery
Lower PEEPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Higher PEEP | Experimental | PEEP of 12 cmH2O or higher and lung recruitment maneuvers Receives: Procedure: Higher PEEP |
| Lower PEEP | Active comparator | PEEP of 4 cmH2O without lung recruitment maneuvers Receives: Procedure: Lower PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Measured: Five postoperative days
Hospital-free days at day 90
Measured: 90 postoperative days
Mortality at day 90
Measured: 90 postoperative days
Postoperative extra-pulmonary complications
Measured: Five postoperative days
Postoperative wound healing
Measured: Five postoperative days
Secondary outcomes (4)
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)
Measured: Surgery period
Need for postoperative ventilatory support
invasive or non-invasive ventilation
Measured: Five postoperative days
Unexpected need for ICU admission or ICU readmission within 30 days
Measured: Five postoperative days
Need for hospital readmission within 30 days
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148692
- Sponsor's protocol ID
- ANE-PROBESE
- Acronym
- PROBESE
- Status last verified
- Jan 2019
- First submitted
- 23 May 2014
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rousseleau D, Bluth T, Bruneel B, Slabbaert M, Serpa Neto A, Schultz MJ, Gama de Abreu M, De Baerdemaeker L; PROBESE Investigators, Protective Ventilation Network, and the Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care. Effect of intraoperative high positive end-expiratory pressure with recruitment manoeuvres versus low positive end-expiratory pressure on postoperative lung function in obese adults: a substudy of the protective ventilation in obese patients randomised controlled trial. BJA Open. 2026 Sep 30;20:100864. doi: 10.1016/j.bjao.2026.100864. eCollection 2026 Dec.
PubMed 42866041Bluth T, Rivas E, Lopez-Baamonde M, Sanahuja JM, Lopez-Hernandez A, Balust J, Weingarten TN, Girrbach F, Simon P, Wrigge H, Wittenstein J, Birr K, Teichmann R, Huhle R, Melchior N, Vivona L, Koch T, Ramakrishna H, Brull S, Serpa Neto A, Schultz MJ, Sprung J, Scharffenberg M, Gama de Abreu M; PROBESE-investigators; Protective Ventilation Network, and the Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care. Association of plasma biomarkers of lung injury with positive end expiratory pressure and postoperative pulmonary complications in obese surgical patients: A substudy of the PROBESE randomised controlled trial. Eur J Anaesthesiol. 2025 Sep 1;42(9):840-850. doi: 10.1097/EJA.0000000000002221. Epub 2025 Jun 20.
PubMed 40548583Scharffenberg M, Mandelli M, Bluth T, Simonassi F, Wittenstein J, Teichmann R, Birr K, Kiss T, Ball L, Pelosi P, Schultz MJ, Gama de Abreu M, Huhle R; PROBESE-investigators; Protective Ventilation Network; Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care. Respiratory mechanics and mechanical power during low vs. high positive end-expiratory pressure in obese surgical patients - A sub-study of the PROBESE randomized controlled trial. J Clin Anesth. 2024 Feb;92:111242. doi: 10.1016/j.jclinane.2023.111242. Epub 2023 Oct 12.
PubMed 37833194Ellenberger 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.
PubMed 36093886Writing 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.
PubMed 31157366Bluth 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.
PubMed 28454590
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients
- ClinicalTrials.gov ID
- NCT02148692
- Acronym / sponsor ID
- PROBESE / ANE-PROBESE
- Conditions
- Morbid Obesity, Surgery, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,013 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- European Society of Anaesthesiology
- Study start
- Jul 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher PEEP | Experimental | Procedure: Higher PEEPPEEP of 12 cmH2O or higher and lung recruitment maneuvers |
| Lower PEEP | Active comparator | Procedure: Lower PEEPPEEP of 4 cmH2O without lung recruitment maneuvers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher PEEP | Procedure or surgery | Higher PEEP |
| Lower PEEP | Procedure or surgery | Lower PEEP |
Primary outcome
Postoperative pulmonary complications
Time frame: Five postoperative days
Hospital-free days at day 90
Time frame: 90 postoperative days
Mortality at day 90
Time frame: 90 postoperative days
Postoperative extra-pulmonary complications
Time frame: Five postoperative days
Postoperative wound healing
Time frame: Five postoperative days
4 secondary outcomes
Intra-operative complications
Time frame: Surgery period
Need for postoperative ventilatory support
Time frame: Five postoperative days
Unexpected need for ICU admission or ICU readmission within 30 days
Time frame: Five postoperative days
Need for hospital readmission within 30 days
Time frame: 30 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 42866041Rousseleau D, Bluth T, Bruneel B, Slabbaert M, Serpa Neto A, Schultz MJ, Gama de Abreu M, De Baerdemaeker L; PROBESE Investigators, Protective Ventilation Network, and the Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care. Effect of intraoperative high positive end-expiratory pressure with recruitment manoeuvres versus low positive end-expiratory pressure on postoperative lung function in obese adults: a substudy of the protective ventilation in obese patients randomised controlled trial. BJA Open. 2026 Sep 30;20:100864. doi: 10.1016/j.bjao.2026.100864. eCollection 2026 Dec.
- Derived from this study: PubMed 40548583Bluth T, Rivas E, Lopez-Baamonde M, Sanahuja JM, Lopez-Hernandez A, Balust J, Weingarten TN, Girrbach F, Simon P, Wrigge H, Wittenstein J, Birr K, Teichmann R, Huhle R, Melchior N, Vivona L, Koch T, Ramakrishna H, Brull S, Serpa Neto A, Schultz MJ, Sprung J, Scharffenberg M, Gama de Abreu M; PROBESE-investigators; Protective Ventilation Network, and the Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care. Association of plasma biomarkers of lung injury with positive end expiratory pressure and postoperative pulmonary complications in obese surgical patients: A substudy of the PROBESE randomised controlled trial. Eur J Anaesthesiol. 2025 Sep 1;42(9):840-850. doi: 10.1097/EJA.0000000000002221. Epub 2025 Jun 20.
- Derived from this study: PubMed 37833194Scharffenberg M, Mandelli M, Bluth T, Simonassi F, Wittenstein J, Teichmann R, Birr K, Kiss T, Ball L, Pelosi P, Schultz MJ, Gama de Abreu M, Huhle R; PROBESE-investigators; Protective Ventilation Network; Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care. Respiratory mechanics and mechanical power during low vs. high positive end-expiratory pressure in obese surgical patients - A sub-study of the PROBESE randomized controlled trial. J Clin Anesth. 2024 Feb;92:111242. doi: 10.1016/j.jclinane.2023.111242. Epub 2023 Oct 12.
- Derived from this study: PubMed 36093886Ellenberger 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.
- Derived from this study: PubMed 31157366Writing 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.
- Derived from this study: PubMed 28454590Bluth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher PEEP and Lower PEEP in people with Morbid Obesity and Surgery, run by Technische Universität Dresden at 24 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Italy, United States, Belgium, Austria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: Five postoperative days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02148692, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.