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

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

Study Overview

• Status: Unknown
• Conditions: Ventilator Lung
• Intervention / Treatment: Procedure: STD-02; Procedure: iOLA-iHFNC

• Study Type: Interventional
• Enrollment (Anticipated): 732
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: STD-02; Conventional standardized lung protective ventilation.	Procedure: STD-02; Conventional standardized ventilatory approach.
Experimental: iOLA-iHFNC; Individualized ventilatory strategy that mantains an open lung condition.	Procedure: iOLA-iHFNC; Indivudualized perioperative open lung ventilatory approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe postoperative pulmonary complications	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.	7 days

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2020
• Primary Completion (Anticipated): January 15, 2021
• Study Completion (Anticipated): August 15, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: iPROVE-EAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No