Individualized Perioperative Open Lung Ventilatory Approach in Emergency Abdominal Laparotomy. A Prospective Multicenter Randomized Controlled Trial.

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Ventilator Lung

Treatments: Procedure: STD-02; Procedure: iOLA-iHFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT04229810

iPROVE-EAL

Details and patient eligibility

About

Prospective multicenter randomized controlled trial. Individualized perioperative open lung ventilatory approach in emergency abdominal laparotomy.

Enrollment: 732 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women ≥18 years of age who underwent emergency laparotomy with the presence of post-induction positive air-test (SpO2 <97% after a maximum of 15 minutes at FIO2 of 0.21). A SpO2 <97% at any FIO2 would also be considered a positive air-test.

Exclusion criteria

• 1. Pregnancy or breast feeding, 2) Moderate or severe ARDS defined, 3) refractory shock, 4) diagnosis or suspected intracranial hypertension (>15mmHg), 5) mechanical ventilation in the last 15 days (including CPAP), 6) presence of pneumothorax or giant bullae in a chest radiograph or computed tomography (CT), 7) patients participating in another intervention study with the same or similar primary outcome variable.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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732 participants in 2 patient groups

STD-02

Active Comparator group

Description:

Conventional standardized lung protective ventilation.

Treatment:

Procedure: STD-02

iOLA-iHFNC

Experimental group

Description:

Individualized ventilatory strategy that mantains an open lung condition.

Treatment:

Procedure: iOLA-iHFNC