Trial | NCT02776046  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    oxygen ...

  • Study Participants

    756
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 Started
Jun 01
2017
Primary Completion
Nov 30
2018
Anticipated
Study Completion
Feb 28
2019
Anticipated
Last Update
Feb 26
2018

Drug High FiO2

High FiO2 with a perioperative open lung strategy

Drug Conventional FiO2

Conventional FiO2 with a perioperative open lung strategy

High FiO2 Experimental

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 Active Comparator

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

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.
No Results Posted