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NOT YET RECRUITING
NCT07170514
NA

EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery

Sponsor: Pest County Flór Ferenc Hospital

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled clinical trial is to compare the pulmonary protective effects of two different positive end-expiratory pressure (PEEP) titrating methods in patients with non-injured lungs undergoing laparoscopic gynecological surgery. Despite dynamic pulmonary compliance (Cdyn) guided lung protective ventilation has several proven advantages, the investigators hypothesize that optimizing intraoperative mechanical ventilation using electrical impedance tomography (EIT) may further improve patient outcomes, enhance postoperative recovery, shorten in-hospital stay and reduce healthcare related costs. The main questions aim to answer are: * May EIT-guided PEEP titration reduce the mechanical power of ventilation and improve oxygenation more significantly than the Cdyn-guided method? * What effect might a decrease in mechanical power of ventilation have on postoperative pulmonary complications? Participants will: * Receive an EIT-guided or a Cdyn-guided PEEP titration procedure during laparoscopic gynecological surgery. * Be assessed for mechanical power of ventilation, oxygenation, atelectasis and postoperative pulmonary complications during and 2 days after surgery. * Be followed-up for mortality until the 28th postoperative day.

Official title: Electrical Impedance Tomography vs Dynamic Compliance Guided Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery: A Multi-center, Prospective Randomized Trial - TITRANT

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-10-01

Completion Date

2027-10-30

Last Updated

2025-09-12

Healthy Volunteers

No

Interventions

PROCEDURE

EIT-guided PEEP titration

During the PEEP titration procedure, PEEP will be decreased from 18 cmH2O by 2 cmH2O every 20 ventilatory cycles, until a final PEEP of 6 cmH2O. On each level of PEEP EIT parameters and Cdyn values will be recorded in both groups. In the EIT-GROUP optimal PEEP is considered as the intersect between the lower percentage of overdistension and collapse, based on the diagnostic tool of the EIT device.

PROCEDURE

Cdyn-guided PEEP titration

During the PEEP titration procedure, PEEP will be decreased from 18 cmH2O by 2 cmH2O every 20 ventilatory cycles, until a final PEEP of 6 cmH2O. On each level of PEEP EIT parameters and Cdyn values will be recorded in both groups. In the Cdyn-GROUP optimal PEEP is considered as the PEEP value resulting the highest possible Cdyn measured by the ventilator.

Locations (3)

Semmelweis Hospital Kiskunhalas

Kiskunhalas, Bács-Kiskun county, Hungary

Flór Ferenc Hospital Kistarcsa

Kistarcsa, Pest County, Hungary

Semmelweis University

Budapest, Hungary