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Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

NCT06215001 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1536

Last updated 2024-01-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Università degli Studi di Ferrara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-12-31
Completion
2025-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215001 on ClinicalTrials.gov