Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation (PEEP-EFL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Mechanical Ventilation Complication
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 1536
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savino Spadaro, PhD; Phone Number: 0532/235605; Email: savino.spadaro@unife.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EFL Positive - intervention; 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.	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.
Active Comparator: EFL Positive - control group; 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.	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.
No Intervention: EFL negative patients; Patients with negative positive end-expiratory pressure test (no expiratory flow limitation) will be treated according to the current evidence and followed up for 7 days after surgery to evaluate the incidence of pulmonary postoperative complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pulmonary complications	The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery	First 7 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: PEEP-EFL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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