EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery

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.

Conditions

• Mechanical Power
• Postoperative Pulmonary Complications (PPCs)
• Oxygenation

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.

Sponsors & Collaborators

• Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

  collaborator OTHER_GOV

• Semmelweis University

  collaborator OTHER

• Pest County Flór Ferenc Hospital

  lead OTHER

Principal Investigators

• Zoltán Ruszkai, MD, PhD · Flór Ferenc Hospital Kistarcsa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-10

Primary Completion

2027-09-30

Completion

2027-10-30

Countries

• Hungary

Study Locations