Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High FiO2 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 |
Drug: High FiO2
High FiO2 with a perioperative open lung strategy
|
| Active Comparator: Conventional FiO2 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 |
Drug: Conventional FiO2
Conventional FiO2 with a perioperative open lung strategy
|
Outcome Measures
Primary Outcome Measures
- Surgical site infection [seven postoperative days]
Secondary Outcome Measures
- Systemic complications [seven postoperative days]
- Pulmonary complications [seven postoperative days]
- Systemic and pulmonary complications [thirty postoperative days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age not less than 18
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Planned abdominal surgery> 2 hours.
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Signed informed consent for participation in the study.
Exclusion Criteria:
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Age less than 18 years.
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Pregnant or breast-feeding.
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Patients with BMI >35.
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Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.
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Heart failure: NYHA IV.
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Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support.
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Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg).
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Mechanical ventilation in the last 15 days.
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Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
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Patient with preoperatively CPAP.
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Participation in another experimental protocol at the time of intervention selection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesia and Critical Care; Hospital Clinico Universitario | Valencia | Spain | 46010 |
Sponsors and Collaborators
- Fundación para la Investigación del Hospital Clínico de Valencia
- Hospital La Fe de Valencia
- Hospital General Universitario de Valencia
- Hospital de Manises
- Hospital de Elche
- Hospital de Villajoyosa
- Hospital San Pau de Barcelona
- Hospital Clinic of Barcelona
- Hospital Germans Tríes i Pujol de Badalona
- Hospital La Princesa de Madrid
- Hospital Gregorio Marañon de Madrid
- Hospital Ramón y Cajal de Madrid
- Hospital Puerta de Hierro de Majalahonda
- Hospital Universitario Fundación Alcorcón
- Hospital Virgen del Rocío de Sevilla
- Hospital Son Espases de Mallorca
- Hospital Dr. Negrin de la Palmas
- Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife
- Hospital de Leon
- Hospital POVISA de Vigo
- Hospital Álvaro Cunqueiro de Vigo
- Hospital de Albacete
- Hospital Principe de Asturias de Madrid
- Hospital Miguel Servet de Zaragoza
- Hospital General de Ciudad Real
- Hospital Río Hortega de Valladolid
Investigators
- Study Director: Javier Belda, Md, PhD, Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Study Documents (Full-Text)
None provided.More Information
Publications
- Belda FJ, Aguilera L, García de la Asunción J, Alberti J, Vicente R, Ferrándiz L, Rodríguez R, Company R, Sessler DI, Aguilar G, Botello SG, Ortí 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. Erratum in: JAMA. 2005 Dec 21;294(23):2973.
- 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.
- Greif R, Akça 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.
- Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Høgdall 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, Heltø 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.
- iPROVE-O2