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

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.

Conditions

• Hyperoxia
• Postoperative Complication
• Surgical Site Infection

Interventions

DRUG

High FiO2

High FiO2 with a perioperative open lung strategy

DRUG

Conventional FiO2

Conventional FiO2 with a perioperative open lung strategy

Sponsors & Collaborators

• Hospital La Fe de Valencia

  collaborator UNKNOWN

• Hospital General Universitario de Valencia

  collaborator OTHER

• Hospital de Manises

  collaborator OTHER

• Hospital de Elche

  collaborator UNKNOWN

• Hospital de Villajoyosa

  collaborator UNKNOWN

• Hospital San Pau de Barcelona

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Germans Tríes i Pujol de Badalona

  collaborator UNKNOWN

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  collaborator OTHER

• Hospital Gregorio Marañon de Madrid

  collaborator UNKNOWN

• Hospital Ramón y Cajal de Madrid

  collaborator UNKNOWN

• Hospital Puerta de Hierro de Majalahonda

  collaborator UNKNOWN

• Hospital Universitario Fundación Alcorcón

  collaborator OTHER

• Hospital Virgen del Rocío de Sevilla

  collaborator UNKNOWN

• Hospital Son Espases de Mallorca

  collaborator UNKNOWN

• Hospital Dr. Negrin de la Palmas

  collaborator UNKNOWN

• Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife

  collaborator UNKNOWN

• Hospital de Leon

  collaborator OTHER_GOV

• Hospital POVISA de Vigo

  collaborator UNKNOWN

• Hospital Álvaro Cunqueiro de Vigo

  collaborator UNKNOWN

• Hospital de Albacete

  collaborator UNKNOWN

• Hospital Principe de Asturias de Madrid

  collaborator UNKNOWN

• Hospital Miguel Servet de Zaragoza

  collaborator UNKNOWN

• Hospital General de Ciudad Real

  collaborator OTHER

• Hospital Río Hortega de Valladolid

  collaborator UNKNOWN

• Fundación para la Investigación del Hospital Clínico de Valencia

  lead OTHER

Principal Investigators

• Javier Belda, Md, PhD · Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2018-11-30

Completion

2019-02-28

Countries

• Spain

Study Locations