Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). (iPROVE-O2)

Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Surgical Site Infection; Hyperoxia; Postoperative Complication
• Intervention / Treatment: Drug: High FiO2; Drug: Conventional FiO2

• Study Type: Interventional
• Enrollment (Anticipated): 756
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: carlos ferrando, MD, PhD; Phone Number: 609892732; Email: cafeoranestesia@gmail.com

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • Department of Anesthesia and Critical Care; Hospital Clinico Universitario
    • Contact: carlos ferrando, MD, PhD; Phone Number: 609892732; Email: cafeoranestesia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age not less than 18
• Planned abdominal surgery> 2 hours.
• Signed informed consent for participation in the study.

Exclusion Criteria:

• Age less than 18 years.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical site infection	seven postoperative days

Secondary Outcome Measures

Outcome Measure	Time Frame
Systemic complications	seven postoperative days
Pulmonary complications	seven postoperative days
Systemic and pulmonary complications	thirty postoperative days

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Collaborators: Hospital Clinic of Barcelona; Hospital de Manises; Hospital General de Ciudad Real; Hospital General Universitario de Valencia; Hospital Universitario Fundación Alcorcón; Hospital de Leon; Hospital La Fe de Valencia; Hospital de Elche; Hospital de Villajoyosa; Hospital San Pau de 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 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 POVISA de Vigo; Hospital Álvaro Cunqueiro de Vigo; Hospital de Albacete; Hospital Principe de Asturias de Madrid; Hospital Miguel Servet de Zaragoza; Hospital Río Hortega de Valladolid
• Investigators: Study Director: Javier Belda, MD, PhD, Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Publications and helpful links

General Publications

• 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, 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.
• 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. Erratum In: JAMA. 2005 Dec 21;294(23):2973.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: May 15, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 23, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Signs and Symptoms, Respiratory; Wound Infection; Postoperative Complications; Surgical Wound Infection; Hyperoxia
• Other Study ID Numbers: iPROVE-O2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No