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

Not Applicable

• Conditions: Hyperoxia; Postoperative Complication; Surgical Site Infection
• Interventions: Drug: High FiO2; Drug: Conventional FiO2

• Registration Number: NCT02776046
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2017-06-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-26
• Primary Completion: 2018-11
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 756

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High FiO2	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
Conventional FiO2	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

Primary Outcome Measures

Name	Time	Method
Surgical site infection	seven postoperative days

Secondary Outcome Measures

Name	Time	Method
Systemic complications	seven postoperative days
Systemic and pulmonary complications	thirty postoperative days
Pulmonary complications	seven postoperative days

Trial Locations

Locations (1)

Department of Anesthesia and Critical Care; Hospital Clinico Universitario; 🇪🇸 Valencia, Spain