Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02148692
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2014-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2013}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2014-05-23', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pulmonary complications', 'timeFrame': 'Five postoperative days'}, {'measure': 'Hospital-free days at day 90', 'timeFrame': '90 postoperative days'}, {'measure': 'Mortality at day 90', 'timeFrame': '90 postoperative days'}, {'measure': 'Postoperative extra-pulmonary complications', 'timeFrame': 'Five postoperative days'}, {'measure': 'Postoperative wound healing', 'timeFrame': 'Five postoperative days'}], 'secondaryOutcomes': [{'measure': 'Intra-operative complications', 'timeFrame': 'Surgery period', '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)'}, {'measure': 'Need for postoperative ventilatory support', 'timeFrame': 'Five postoperative days', 'description': 'invasive or non-invasive ventilation'}, {'measure': 'Unexpected need for ICU admission or ICU readmission within 30 days', 'timeFrame': 'Five postoperative days'}, {'measure': 'Need for hospital readmission within 30 days', 'timeFrame': '30 postoperative days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Morbid Obesity', 'Surgery', 'General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '40548583', 'type': 'DERIVED', 'citation': 'Bluth 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.'}, {'pmid': '37833194', 'type': 'DERIVED', 'citation': 'Scharffenberg 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.'}, {'pmid': '36093886', 'type': 'DERIVED', '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.'}, {'pmid': '31157366', 'type': 'DERIVED', '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.'}, {'pmid': '28454590', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient scheduled for open or laparoscopic surgery under general anesthesia\n* Intermediate-to-high risk for PPCs following surgery, according to the ARISCAT risk score (≥ 26)\n* BMI ≥ 35 kg/m2\n* Expected duration of surgery ≥ 2 h\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Previous lung surgery (any)\n* Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician)\n* 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)\n* Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)\n* Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)\n* Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days\n* Pregnancy (excluded by anamneses and/or laboratory analysis)\n* Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation\n* Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \\> 40 mmHg\n* Intracranial injury or tumor\n* Neuromuscular disease (any)\n* Need for intraoperative prone or lateral decubitus position\n* Need for one-lung ventilation\n* Cardiac surgery\n* Neurosurgery\n* Planned reintubation following surgery\n* Enrolled in other interventional study or refusal of informed consent"}, 'identificationModule': {'nctId': 'NCT02148692', 'acronym': 'PROBESE', 'briefTitle': 'Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'orgStudyIdInfo': {'id': 'ANE-PROBESE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Higher PEEP', 'description': 'PEEP of 12 cmH2O or higher and lung recruitment maneuvers', 'interventionNames': ['Procedure: Higher PEEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lower PEEP', 'description': 'PEEP of 4 cmH2O without lung recruitment maneuvers', 'interventionNames': ['Procedure: Lower PEEP']}], 'interventions': [{'name': 'Higher PEEP', 'type': 'PROCEDURE', 'armGroupLabels': ['Higher PEEP']}, {'name': 'Lower PEEP', 'type': 'PROCEDURE', 'armGroupLabels': ['Lower PEEP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital, Harvard University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge-Oostende AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'ABC Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Toronto', 'country': 'Canada', 'facility': "Saint Michael's Hospital, University of Toronto", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Saint Eloi University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'University of Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Foggia', 'country': 'Italy', 'facility': 'University of Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Genoa', 'country': 'Italy', 'facility': 'University of Genoa', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'city': 'Turin', 'country': 'Italy', 'facility': 'Città della Salute e della Scienza', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'University of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center, University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias I Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'University Hospital Uppsala', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'University of Istanbul', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society of Anaesthesiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}