Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

NCT06215001 | Unknown

• 1 other identifier: PEEP-EFL
• Study Type: interventional
• Target: 1,536
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Complications; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative Oxygenation

  Within 2 hours after surgery

• Need for intubation or non-invasive ventilation

  First 7 days after surgery

• Days of hospitalization

  From hospital entrance to hospital discharge, assessed up to 30 days

• Need for Intensive Care admission

  From hospital entrance to hospital discharge, assessed up to 30 days

• Length of stay in ICU

  From intensive care entrance to intensive care discharge, assessed up to 30 days

Study Arms (3)

EFL Positive - intervention

EXPERIMENTAL

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

EFL Positive - control group

ACTIVE COMPARATOR

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

EFL negative patients

NO INTERVENTION

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.

Interventions

Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation PROCEDURE

Positive End expiratory pressure will be set according to the positive end-expiratory pressure able to revert the expiratory flow limitation.

EFL Positive - intervention

Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation PROCEDURE

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.

EFL Positive - control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

MeSH Terms

Conditions

Postoperative Complications

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Savino Spadaro, PhD

CONTACT

0532/235605; savino.spadaro@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01