Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

NCT ID: NCT06215001

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Savino Spadaro

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Savino Spadaro, PhD

Role: CONTACT

savino.spadaro@unife.it

0532/235605

Other Identifiers

PEEP-EFL

Identifier Type: -

Identifier Source: org_study_id