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| Name | Class |
|---|---|
| Hospital de Manises | OTHER |
| Hospital General Valencia | OTHER |
| Hospital Universitario La Fe | OTHER |
| Germans Trias i Pujol Hospital |
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The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized ventilation | Experimental | Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. |
|
| Individualized vent. + postop. CPAP | Experimental | Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied. |
|
| Standard ventilation | No Intervention | Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, PEEP 6 cmH2O and FiO2 0.8. In these groups no recruitment maneuvers or optimal PEEP setting will be performed. | |
| Standard vent. + postoperative CPAP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alveolar recruitment maneuver | Procedure | To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of lung and systemic postoperative complications | Up to 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of lung and systemic postoperative complications | Up to 30 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality evaluation | 180 and 365 days postoperative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Ferrando, MD, PhD | Hospital Clínico Universitario Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | MA 02114 | United States | ||
| Hospital Privado de la Comunidad |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23902482 | Background | Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082. | |
| 24894577 |
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| OTHER |
| Hospital de Sant Pau | OTHER |
| Hospital del Mar | OTHER |
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital General Universitario de Alicante | OTHER |
| Hospital Juan Canalejo | OTHER |
| Hospital General Regional de León | OTHER_GOV |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Hospital Miguel Servet | OTHER |
| Hospital Clínico Universitario de Valladolid | OTHER |
| Hospital Universitario Fundación Alcorcón | OTHER |
| Hospital General de Ciudad Real | OTHER |
| Hospital Universitario de Valme | OTHER |
| Hospital de Basurto | OTHER |
| Hospital Dr. Negrín | UNKNOWN |
| Hospital de Galdakano | UNKNOWN |
| Complejo Hospitalario de Especialidades Juan Ramón Jimenez | OTHER |
| Puerta de Hierro University Hospital | OTHER |
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| Active Comparator |
Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, PEEP 6 cmH2O and FiO2 0.8. In these groups no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied. |
|
|
| Calculation of optimal PEEP | Procedure | Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O . |
|
| Postoperative CPAP | Procedure | Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied. |
|
| Mar del Plata |
| Buenos Aires |
| 7600 |
| Argentina |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona | 08026 | Spain |
| Hospital Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| Department of Anesthesia and Critical Care; Hospital Clinico Universitario | Valencia | Valencia | 46010 | Spain |
| Uppsala University Hospital | Uppsala | Uppland | Sweden |
| PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2. |
| 23093163 | Background | Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730. |
| 34460936 | Derived | Ferrando C, Librero J, Tusman G, Serpa-Neto A, Villar J, Belda FJ, Costa E, Amato MBP, Suarez-Sipmann F; iPROVE Network Group. Intraoperative open lung condition and postoperative pulmonary complications. A secondary analysis of iPROVE and iPROVE-O2 trials. Acta Anaesthesiol Scand. 2022 Jan;66(1):30-39. doi: 10.1111/aas.13979. Epub 2021 Sep 22. |
| 32028288 | Derived | Garutti I, Errando CL, Mazzinari G, Bellon JM, Diaz-Cambronero O, Ferrando C; iPROVE network. Spontaneous recovery of neuromuscular blockade is an independent risk factor for postoperative pulmonary complications after abdominal surgery: A secondary analysis. Eur J Anaesthesiol. 2020 Mar;37(3):203-211. doi: 10.1097/EJA.0000000000001128. |
| 29371130 | Derived | Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19. |
| 25927183 | Derived | Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1. |
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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