NCT06215001

Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,536 (estimated)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question\[s\] it aims to answer are: * If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary postoperative complications; * If patients with expiratory flow limitation have a higher incidence of pulmonary postoperative complications as compared to patients with no expiratory flow limitation; Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation: * Personalized positive end-expiratory pressure based on EFL * Standard of care positive end-expiratory pressure Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.

Conditions

• Postoperative Complications
• Mechanical Ventilation Complication

Interventions

Type	Name	Description
PROCEDURE	Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation	Positive End expiratory pressure will be set according to the positive end-expiratory pressure able to revert the expiratory flow limitation.
PROCEDURE	Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation	Positive End expiratory pressure will be set not according to the positive end-expiratory pressure able to revert the expiratory flow limitation but to a standard level of 4 cmH2O.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-31
• Completion: 2025-03-01
• First posted: 2024-01-22
• Last updated: 2024-01-22