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

Not Applicable

• Conditions: Ventilator Lung
• Interventions: Procedure: STD-02; Procedure: iOLA-iHFNC

• Registration Number: NCT04229810
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Last Update Submitted: 2020-01-13
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Study Start: 2020-09-15
• Primary Completion: 2021-01-15
• Study Completion: 2021-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 732

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STD-02	STD-02	Conventional standardized lung protective ventilation.
iOLA-iHFNC	iOLA-iHFNC	Individualized ventilatory strategy that mantains an open lung condition.

Primary Outcome Measures

Name	Time	Method
Severe postoperative pulmonary complications	7 days	A composite of severe postoperative pulmonary complications appearing during the first 7 postoperative days. Postoperative pulmonary complication will include any of the following: 1) Respiratory failure, 2) Pneumothorax, 3) Weaning failure, 4) Acute respiratory distress syndrome (ARDS), 5) Pulmonary infection.