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BMJ Open. 2017 Jul 31;7(7):e016765. doi: 10.1136/bmjopen-2017-016765.

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.

Author information

1
Department of Anesthesiology and Critical Care, Hospital Clínico Universitario, Valencia, Spain.
2
Department of Anesthesiology and Critical Care, Hospital de la Santa Creu i Sant Pau, Valencia, Spain.
3
Department of Anesthesiology and Critical Care, Hospital Germans Tries i Pujol, Badalona, Spain.
4
Department of Anesthesiology, Hospital Privado de Comunidad, Mar de Plata, Argentina.
5
CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
6
Department of Surgical Sciences, Hedenstierna Laboratory, Uppsala University Hospital, Uppsala, Sweden.
7
Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Navarrabiomed Fundación Miguel Servet, Pamplona, Spain.
8
Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Centro Superior de Investigación en Salud Pública (CSISP FISABIO), Valencia, Spain.
9
Department of Anesthesiology, Hospital de Villajoyosa, Villajoyosa, Spain.
10
Department of Anesthesiology and Critical Care, Hospital de Villajoyosa, Villajoyosa, Spain.
11
Department of Anesthesiology and Critical Care, Hospital General Gregorio Marañon, Madrid, Spain.
12
Anesthesiology and Critical Care, Hospital Ramón y Cajal, Madrid, Spain.
13
Anesthesiology and Critical Care, Hospital Dr. Negrín, Gran Canaria, Spain.
14
Anesthesiology and Critical Care, Hospital Fundación of Alcorcón, Alcorcón, Spain.
15
Hospital La Fe, Anesthesiology and Critical Care, Valencia, Spain.
16
Anesthesiology and Critical Care, Hospital Clínic i Provincial, Barcelona, Spain.
17
Anesthesiology and Critical Care, Hospital General, Ciudad Real, Spain.
18
Anesthesiology and Critical Care, Hospital Vírgen del Rocio, Seville, Spain.
19
Anesthesiology and Critical Care, Hospital Miguel Servet, Zaragoza, Spain.
20
Anesthesiology and Critical Care, Hospital General, Valencia, Spain.
21
Anesthesiology and Critical Care, Hospital de Albacete, Albacete, Spain.
22
Anesthesiology and Critical Care, Hospital of Elche, Elche, Spain.
23
Anesthesiology and Critical Care, Hospital Povisa, Vigo, Spain.
24
Anesthesiology and Critical Care, Hospital La Princesa, Madrid, Spain.
25
Anesthesiology and Critical Care, Hospital 12 de Octubre, Madrid, Spain.
26
Anesthesiology and Critical Care, Clínica Universidad de Navarra, Pamplona, Spain.
27
Anesthesiology and Critical Care, Hospital Universitario de León, León, Spain.
28
Anesthesiology and Critical Care, Hospital de Manises, Manises, Spain.
29
Multidisciplinary Organ Dysfunction Evaluation Research Network, Research Unit, Hospital Universitario Dr. Negrin, Las Palmas de Gran Canaria, Gran Canaria, Spain.
30
Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.

Abstract

INTRODUCTION:

Surgical site infection (SSI) is a serious postoperative complication that increases morbidity and healthcare costs. SSIs tend to increase as the partial pressure of tissue oxygen decreases: previous trials have focused on trying to reduce them by comparing high versus conventional inspiratory oxygen fractions (FIO2) in the perioperative period but did not use a protocolised ventilatory strategy. The open-lung ventilatory approach restores functional lung volume and improves gas exchange, and therefore it may increase the partial pressure of tissue oxygen for a given FIO2. The trial presented here aims to compare the efficacy of high versus conventional FIO2 in reducing the overall incidence of SSIs in patients by implementing a protocolised and individualised global approach to perioperative open-lung ventilation.

METHODS AND ANALYSIS:

This is a comparative, prospective, multicentre, randomised and controlled two-arm trial that will include 756 patients scheduled for abdominal surgery. The patients will be randomised into two groups: (1) a high FIO2 group (80% oxygen; FIO2 of 0.80) and (2) a conventional FIO2 group (30% oxygen; FIO2 of 0.30). Each group will be assessed intra- and postoperatively. The primary outcome is the appearance of postoperative SSI complications. Secondary outcomes are the appearance of systemic and pulmonary complications.

ETHICS AND DISSEMINATION:

The iPROVE-O2 trial has been approved by the Ethics Review Board at the reference centre (the Hospital Clínico Universitario in Valencia). Informed consent will be obtained from all patients before their participation. If the approach using high FIO2 during individualised open-lung ventilation decreases SSIs, use of this method will become standard practice for patients scheduled for future abdominal surgery. Publication of the results is anticipated in early 2019.

TRIAL REGISTRATION NUMBER:

NCT02776046; Pre-results.

KEYWORDS:

open lung ventilation; oxygen; perioperative; surgical site infection

PMID:
28760799
PMCID:
PMC5642673
DOI:
10.1136/bmjopen-2017-016765
[Indexed for MEDLINE]
Free PMC Article

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