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| Name | Class |
|---|---|
| Hospital Universitario La Fe | OTHER |
| Hospital General Universitario de Valencia | OTHER |
| Hospital de Manises | OTHER |
| Hospital de Elche |
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The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High FiO2 | 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. Postoperatively 3h with 0.8 FiO2 and individualized CPAP |
|
| Conventional FiO2 | Active Comparator | Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.3. 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 3h with 0.3 FiO2 and individualized CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High FiO2 | Drug | High FiO2 with a perioperative open lung strategy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | seven postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic complications | seven postoperative days | |
| Pulmonary complications | seven postoperative days | |
| Systemic and pulmonary complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Ferrando, MD, PhD | Contact | 609892732 | cafeoranestesia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Javier Belda, Md, PhD | Department of Anesthesia and Critical Care; Hospital Clinico Universitario | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia and Critical Care; Hospital Clinico Universitario | Recruiting | Valencia | 46010 | Spain |
| 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. | |
| 16249417 |
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| UNKNOWN |
| Hospital de Villajoyosa | UNKNOWN |
| Hospital San Pau de Barcelona | UNKNOWN |
| Hospital Clinic of Barcelona | OTHER |
| Hospital Germans Tríes i Pujol de Badalona | UNKNOWN |
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Hospital Gregorio Marañon de Madrid | UNKNOWN |
| Hospital Ramón y Cajal de Madrid | UNKNOWN |
| Puerta de Hierro University Hospital | OTHER |
| Hospital Universitario Fundación Alcorcón | OTHER |
| Hospitales Universitarios Virgen del Rocío | OTHER |
| Hospital Son Espases de Mallorca | UNKNOWN |
| Hospital Universitario de Gran Canaria Doctor Negrín | OTHER |
| Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife | UNKNOWN |
| Hospital de Leon | OTHER_GOV |
| Hospital POVISA de Vigo | UNKNOWN |
| Hospital Álvaro Cunqueiro de Vigo | UNKNOWN |
| Hospital de Albacete | UNKNOWN |
| Hospital Principe de Asturias de Madrid | UNKNOWN |
| Hospital Miguel Servet de Zaragoza | UNKNOWN |
| Hospital General de Ciudad Real | OTHER |
| Hospital Río Hortega de Valladolid | UNKNOWN |
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| Conventional FiO2 |
| Drug |
Conventional FiO2 with a perioperative open lung strategy |
|
| thirty postoperative days |
| Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035. |
| 19826023 | Background | Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452. |
| 10639541 | Background | Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303. |
| 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. |
| 31767144 | Derived | Ferrando C, Aldecoa C, Unzueta C, Belda FJ, Librero J, Tusman G, Suarez-Sipmann F, Peiro S, Pozo N, Brunelli A, Garutti I, Gallego C, Rodriguez A, Garcia JI, Diaz-Cambronero O, Balust J, Redondo FJ, de la Matta M, Gallego-Ligorit L, Hernandez J, Martinez P, Perez A, Leal S, Alday E, Monedero P, Gonzalez R, Mazzirani G, Aguilar G, Lopez-Baamonde M, Felipe M, Mugarra A, Torrente J, Valencia L, Varon V, Sanchez S, Rodriguez B, Martin A, India I, Azparren G, Molina R, Villar J, Soro M; iPROVE-O2 Network. Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):110-120. doi: 10.1016/j.bja.2019.10.009. Epub 2019 Nov 22. |
| 28760799 | Derived | Ferrando C, Soro M, Unzueta C, Canet J, Tusman G, Suarez-Sipmann F, Librero J, Peiro S, Pozo N, Delgado C, Ibanez M, Aldecoa C, Garutti I, Pestana D, Rodriguez A, Garcia Del Valle S, Diaz-Cambronero O, Balust J, Redondo FJ, De La Matta M, Gallego L, Granell M, Martinez P, Perez A, Leal S, Alday K, Garcia P, Monedero P, Gonzalez R, Mazzinari G, Aguilar G, Villar J, Belda FJ; iPROVE-O2 Network Group. Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016765. doi: 10.1136/bmjopen-2017-016765. |
| ID | Term |
|---|---|
| D018496 | Hyperoxia |
| D011183 | Postoperative Complications |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D014946 | Wound Infection |
| D007239 | Infections |
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