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

F

Fundación para la Investigación del Hospital Clínico de Valencia

Status

Unknown

Conditions

Postoperative Complication
Surgical Site Infection
Hyperoxia

Treatments

Drug: High FiO2
Drug: Conventional FiO2

Study type

Interventional

Funder types

Other

Identifiers

NCT02776046
iPROVE-O2

Details and patient eligibility

About

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.

Enrollment

756 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

756 participants in 2 patient groups

High FiO2
Experimental group
Description:
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
Treatment:
Drug: High FiO2
Conventional FiO2
Active Comparator group
Description:
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
Treatment:
Drug: Conventional FiO2

Trial contacts and locations

1

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Central trial contact

Carlos Ferrando, MD, PhD

Data sourced from clinicaltrials.gov

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