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

Hospital Clinic of Barcelona0 sites732 target enrollmentSeptember 15, 2020

ConditionsVentilator Lung

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventilator Lung
Sponsor: Hospital Clinic of Barcelona
Enrollment: 732
Primary Endpoint: Severe postoperative pulmonary complications
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 15, 2020

End Date

August 15, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Clinic of Barcelona

Responsible Party

Principal Investigator

Carlos Ferrando Ortolá

Head of Surgical Intensive Care Unit

Hospital Clinic of Barcelona

Eligibility Criteria

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

•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.

Outcomes

Primary Outcomes

Severe postoperative pulmonary complications

Time Frame: 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.