RecruitingNot ApplicableNCT07170514

EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery

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


Sponsor

Pest County Flór Ferenc Hospital

Enrollment

200 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • Patient scheduled for elective laparoscopic gynaecological surgery
  • Age > 18 years
  • Signed consent to participate in the trial

Exclusion Criteria10

  • Age < 18 years
  • American Society of Anesthesiologists (ASA) physical status IV
  • History of severe restrictive or chronic obstructive pulmonary disease (COPD, Global Initiative for Chronic Obstructive Lung Disease grades III or IV)
  • Uncontrolled bronchial asthma
  • Pulmonary metastases
  • History of any thoracic surgery
  • Need for thoracic drainage before surgery
  • Congestive heart failure (NYHA grades III or IV)
  • Extreme obesity (BMI>35 kg m-2)
  • Lack of patient's consent

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Interventions

PROCEDUREEIT-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.

PROCEDURECdyn-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 University

Budapest, Budapest, Hungary

Semmelweis Hospital Kiskunhalas

Kiskunhalas, Bács-Kiskun county, Hungary

Flór Ferenc Hospital Kistarcsa

Kistarcsa, Pest County, Hungary

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NCT07170514


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