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

Conditions

Hyperoxia, Postoperative Complication, Surgical Site Infection

Keywords

Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy

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.

Carlos Ferrando, Julián Librero, Gerardo Tusman, Ary Serpa Neto, Jesús Villar et al. (10 authors)

Acta Anaesthesiologica Scandinavica2021-08-3016 citations

10.1111/aas.13979

Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial.

Ferrando C, Aldecoa C, Unzueta C, Belda FJ, Librero J, Tusman G, Suárez-Sipmann F, Peiró S, Pozo N, Brunelli A, Garutti I, Gallego C, Rodríguez A, García JI, Díaz-Cambronero O, Balust J, Redondo FJ, de la Matta M, Gallego-Ligorit L, Hernández J, Martínez P, Pérez A, Leal S, Alday E, Monedero P, González R, Mazzirani G, Aguilar G, López-Baamonde M, Felipe M, Mugarra A, Torrente J, Valencia L, Varón V, Sánchez S, Rodríguez B, Martín A, India I, Azparren G, Molina R, Villar J, Soro M, iPROVE-O2 Network.

2019-11-2234 citations

10.1016/j.bja.2019.10.009

PROtective Ventilation with a low versus high Inspiratory Oxygen fraction (PROVIO) and its effects on postoperative pulmonary complications: protocol for a randomized controlled trial

Xuefei Li, Dan Jiang, Yu-Lian Jiang, Hong Yu, Jia-Li Jiang et al. (8 authors)

Trials2019-11-017 citations

10.1186/s13063-019-3668-x

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

Carlos Ferrando, Marina Soro, Carmen Unzueta, Jaume Canet, Gerardo Tusman et al. (33 authors)

BMJ Open2017-07-0117 citations

10.1136/bmjopen-2017-016765

Interventions

DRUGHigh FiO2

High FiO2 with a perioperative open lung strategy

DRUGConventional FiO2

Conventional FiO2 with a perioperative open lung strategy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
Surgical site infection	seven postoperative days

Secondary

Measure	Time frame
Systemic complications	seven postoperative days
Pulmonary complications	seven postoperative days
Systemic and pulmonary complications	thirty postoperative days

Countries

Spain

Contacts

Primary ContactCarlos Ferrando, MD, PhD

cafeoranestesia@gmail.com609892732

Outcome results

None listed