Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).
NCT ID: NCT02776046
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
756 participants
INTERVENTIONAL
2017-06-01
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
High FiO2
High FiO2 with a perioperative open lung strategy
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
Conventional FiO2
Conventional FiO2 with a perioperative open lung strategy
Interventions
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High FiO2
High FiO2 with a perioperative open lung strategy
Conventional FiO2
Conventional FiO2 with a perioperative open lung strategy
Eligibility Criteria
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Inclusion Criteria
* Planned abdominal surgery\> 2 hours.
* Signed informed consent for participation in the study.
Exclusion Criteria
* Pregnant or breast-feeding.
* Patients with BMI \>35.
* Syndrome of moderate or severe respiratory distress: PaO2/FiO2 \< 200 mmHg.
* Heart failure: NYHA IV.
* Hemodynamic failure: CI \<2.5 L/min/m2 and / or requirements before surgery ionotropic support.
* Diagnosis or suspicion of intracranial hypertension (intracranial pressure\> 15 mmHg).
* Mechanical ventilation in the last 15 days.
* Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
* Patient with preoperatively CPAP.
* Participation in another experimental protocol at the time of intervention selection.
18 Years
ALL
No
Sponsors
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Hospital La Fe de Valencia
UNKNOWN
Hospital General Universitario de Valencia
OTHER
Hospital de Manises
OTHER
Hospital de Elche
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
Hospital Puerta de Hierro de Majalahonda
UNKNOWN
Hospital Universitario Fundación Alcorcón
OTHER
Hospital Virgen del Rocío de Sevilla
UNKNOWN
Hospital Son Espases de Mallorca
UNKNOWN
Hospital Dr. Negrin de la Palmas
UNKNOWN
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
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Carlos Ferrando
MD,PhD
Principal Investigators
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Javier Belda, Md, PhD
Role: STUDY_DIRECTOR
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Locations
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Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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iPROVE-O2
Identifier Type: -
Identifier Source: org_study_id
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