Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

Not Applicable

Not yet recruiting

• Conditions: Mechanical Ventilation Complication; Postoperative Complications
• Interventions: Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation; Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation

• Registration Number: NCT06215001
• Lead Sponsor: Università degli Studi di Ferrara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-06
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Study Start: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1536

Inclusion Criteria

• Ages between 18 and 90 years old;
• Patients undergoing laparoscopic, robotic surgery
• Surgery performed in elective regimen;
• Length of mechanical ventilation more than 120 minutes;
• Presence of invasive pressure monitoring for clinical purposes;

Exclusion Criteria

• Age < 18 or > 90;
• Severe chronic obstructive pulmonary disease with GOLD stage 3 or 4;
• Length of mechanical ventilation less than 120 minutes;
• Unplanned conversion to laparotomy surgery;
• Refusal to participate by the patient;
• Anesthesia maintenance using Desflurane.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EFL Positive - intervention	Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation	Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be therefore set according to this value.
EFL Positive - control group	Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation	Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be set at a fixed level of 4 cmH2O.

Primary Outcome Measures

Name	Time	Method
Postoperative pulmonary complications	First 7 days after surgery	The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery

Secondary Outcome Measures

Name	Time	Method
Need for intubation or non-invasive ventilation	First 7 days after surgery	The investigators will evaluate the need for intubation or non-invasive ventilation
Need for Intensive Care admission	From hospital entrance to hospital discharge, assessed up to 30 days	The investigators will evaluate the need for Intensive Care admission
Postoperative Oxygenation	Within 2 hours after surgery	The investigators will evaluate postoperative oxygenation after surgery
Days of hospitalization	From hospital entrance to hospital discharge, assessed up to 30 days	The investigators will evaluate the number of days of hospital stay
Length of stay in ICU	From intensive care entrance to intensive care discharge, assessed up to 30 days	The investigators will evaluate the length of Intensive care unit stay