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

• Status: Unknown status
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Collaborators: Hospital Álvaro Cunqueiro de Vigo; Hospital Clinic of Barcelona; Hospital de Albacete; Hospital de Elche; Hospital de Leon; Hospital de Manises; Hospital de Villajoyosa; Hospital Dr. Negrin de la Palmas; Hospital Fundación de Alcorcon; Hospital General de Ciudad Real; Hospital General de Valencia; Hospital General Universitario de Valencia; Hospital Germans Tríes i Pujol de Badalona; Hospital Gregorio Marañon de Madrid; Hospital La Fe de Valencia; Hospital La Princesa de Madrid; Hospital Miguel Servet de Zaragoza; Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife; Hospital POVISA de Vigo; Hospital Principe de Asturias de Madrid; Hospital Puerta de Hierro de Majalahonda; Hospital Ramón y Cajal de Madrid; Hospital Río Hortega de Valladolid; Hospital San Pau de Barcelona; Hospital Son Espases de Mallorca; Hospital Universitario Fundación Alcorcón; Hospital Virgen del Rocío de Sevilla

Criteria

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.