Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 756
- Locations
- 1
- Primary Endpoint
- Surgical site infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 >
- •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.
Arms & Interventions
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
Intervention: High FiO2 (Drug)
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
Intervention: Conventional FiO2 (Drug)
Outcomes
Primary Outcomes
Surgical site infection
Time Frame: seven postoperative days
Secondary Outcomes
- Systemic complications(seven postoperative days)
- Systemic and pulmonary complications(thirty postoperative days)
- Pulmonary complications(seven postoperative days)
Investigators
Carlos Ferrando
MD,PhD
Fundación para la Investigación del Hospital Clínico de Valencia