Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation

Postoperative Complications Clinical Trial

— PEEP-EFL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215001
• Other study ID #: PEEP-EFL
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Università degli Studi di Ferrara
• Contact: Savino Spadaro, PhD
• Phone: 0532/235605
• Email: savino.spadaro[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1536
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Postoperative Complications

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative Oxygenation	The investigators will evaluate postoperative oxygenation after surgery	Within 2 hours after surgery
Secondary	Need for intubation or non-invasive ventilation	The investigators will evaluate the need for intubation or non-invasive ventilation	First 7 days after surgery
Secondary	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
Secondary	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
Secondary	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