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

Study Overview
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Brief Summary
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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.

Official Title
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Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial

Conditions
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Hyperoxia, Postoperative Complication, Surgical Site Infection

Intervention / Treatment
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* Drug: High FiO2
* Drug: Conventional FiO2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High FiO2<br>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 | Drug: High FiO2<br>* High FiO2 with a perioperative open lung strategy<br>|
| Active Comparator: Conventional FiO2<br>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 | Drug: Conventional FiO2<br>* Conventional FiO2 with a perioperative open lung strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection |  | seven postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic complications |  | seven postoperative days | 
| Pulmonary complications |  | seven postoperative days | 
| Systemic and pulmonary complications |  | thirty postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy