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| Name | Class |
|---|---|
| European Society of Anaesthesiology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher PEEP | Experimental | PEEP of 12 cmH2O or higher and lung recruitment maneuvers |
|
| Lower PEEP | Active Comparator | PEEP of 4 cmH2O without lung recruitment maneuvers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher PEEP | Procedure |
| ||
| Lower PEEP |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pulmonary complications | Five postoperative days | |
| Hospital-free days at day 90 | 90 postoperative days | |
| Mortality at day 90 | 90 postoperative days | |
| Postoperative extra-pulmonary complications | Five postoperative days | |
| Postoperative wound healing | Five postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Need for postoperative ventilatory support |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital, Harvard University | Boston | Massachusetts | United States | |||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40548583 | Derived | 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. | |
| 37833194 |
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|
invasive or non-invasive ventilation |
| Five postoperative days |
| Unexpected need for ICU admission or ICU readmission within 30 days | Five postoperative days |
| Need for hospital readmission within 30 days | 30 postoperative days |
| Rochester |
| Minnesota |
| United States |
| Medical University | Vienna | Austria |
| AZ Sint Jan Brugge-Oostende AV | Bruges | Belgium |
| Ghent University Hospital | Ghent | Belgium |
| ABC Medical School | São Paulo | Brazil |
| Saint Michael's Hospital, University of Toronto | Toronto | Canada |
| Saint Eloi University Hospital | Montpellier | France |
| Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus | Dresden | Saxony | 01307 | Germany |
| University of Aachen | Aachen | Germany |
| University of Bonn | Bonn | Germany |
| University of Leipzig | Leipzig | Germany |
| Semmelweis Egyetem | Budapest | Hungary |
| Tel Aviv Medical Center | Tel Aviv | Israel |
| University of Foggia | Foggia | Italy |
| University of Genoa | Genoa | Italy |
| Città della Salute e della Scienza | Turin | Italy |
| University of Insubria | Varese | Italy |
| Academic Medical Center, University of Amsterdam | Amsterdam | Netherlands |
| Hospital Universitari Germans Trias I Pujol | Barcelona | Spain |
| University Hospital Uppsala | Uppsala | Sweden |
| Hôpitaux Universitaires de Genève | Geneva | Switzerland |
| University of Istanbul | Istanbul | Turkey (Türkiye) |
| Sheffield Teaching Hospitals | Sheffield | United Kingdom |
| Derived |
| 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. |
| 36093886 | Derived | 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. |
| 31157366 | Derived | 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. |
| 28454590 | Derived | 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. |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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