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NCT Number: NCT07170514

EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Budapest, Hungary

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About this study

The aim of this study is to compare the effects of two different - electrical impedance tomography guided (EIT) versus dynamic pulmonary compliance guided (Cdyn) - positive end-expiratory pressure (PEEP) titrating methods on mechanical power of ventilation (MP), oxygenation, respiratory mechanics parameters, global inhomogeneity index (GI), overdistension/collapse (ODCL) and postoperative pulmonary complications (PPCs) in patients with non-injured lungs undergoing laparoscopic gynecological surgery. Despite Cdyn-directed lung protective ventilation has several proven advantages, the investigators hypothesize that optimizing intraoperative mechanical ventilation using EIT may further improve patient outcomes by reducing MP responsible for ventilator induced lung injury (VILI) and consequent PPCs. These anticipated advantages may improve the knowledge about individualized intraoperative protective ventilation, enhance postoperative recovery, shorten in-hospital stay and reduce healthcare related costs.

A total number of 200 patients scheduled for laparoscopic gynecological surgery will be enrolled in this study. An equal number of patients will be randomized into the PEEP-EIT and PEEP-Cdyn groups.

Patients randomized into the PEEP-EIT group receive a decremental PEEP titration procedure directed by EIT PEEP Trial of the Dräger PulmoVista 500 device in order to determine the individually optimal level of PEEP (PEEPopt). Patients in the PEEP-Cdyn Group will undergo the same decremental PEEP titration procedure directed by Cdyn measured by the ventilator of the anesthesia workstation.

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 Cdyn values will be recorded. In the PEEP-EIT Group PEEPopt is considered as the intersect between the lower percentage of overdistension and collapse, based on the diagnostic tool of the EIT device. In the PEEP-Cdyn Group optimal PEEP is considered as the PEEP value resulting the highest possible Cdyn measured by the ventilator After the titration procedure, a lung protective mechanical ventilation (LPV) will be performed using PEEPopt and low tidal volumes (TV=6 mL/kg, Ideal Body Weight) in both groups.

Mechanical Power, driving pressure, Cdyn, tidal volume in region of interest 3 and 4 (TVROI3, TVROI4) and end-expiratory lung volumes will be recorded immediately after the PEEP titration trial and every 15 minutes during surgery in both groups.

Oxygenation and dead space fraction indicated by the ratio of arterial oxygen partial pressure to fraction of inspired oxygen (PaO2/FiO2) and arterial to end-tidal carbon dioxide difference, respectively, will be recorded every 30 minutes during surgery in both groups. PaO2/FiO2 ratio will be recorded immediately after extubation and 30 mins, 2, 6, 12, 24 and 48 hours after surgery also.

GI and ODCL will be evaluated retrospectively after surgery using the EIT Diag SW 1.6 diagnostic software for Dräger PulmoVista 500.

During the first and second postoperative days EIT measurements will be performed for atelectasis, while arterial blood gas samples will be assessed to screen gas exchange parameters and laboratory examinations will be performed for Sequential Organ Failure Assessment (SOFA) Scores indicating patients' postoperative clinical conditions.

A follow-up period will be performed for mortality until the 28th day after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

EIT-guided PEEP titration

Procedure

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.

Cdyn-guided PEEP titration

Procedure

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.

Primary outcomes

  1. Mechanical Power (MP)

    Time frame: During surgery

    MP is calculated using a comprehensive formula for volume-controlled ventilator mode:

    MP = 0.098 x RR x TV (L) x [ Ppeak - ½ x (Pplat - PEEP)]

    (RR: respiratory rate TV: tidal volume Ppeak: airway peak pressure Pplat: plateau pressure PEEP: positive end-expiratory pressure)

Secondary outcomes

  1. Oxygenation

    Time frame: From the beginning of surgery to 48 hours after surgery

    Oxygenation indicated by the PaO2/FiO2 ratio

  2. Positive end-expiratory pressure (PEEP)

    Time frame: During surgery

    The level of individually optimal PEEP determined during a PEEP titration procedure

  3. Dynamic pulmonary compliance (Cdyn)

    Time frame: During surgery

    Dynamic pulmonary compliance measured by the ventilator during mechanical ventilation

  4. Driving pressure (dP)

    Time frame: During surgery

    Driving pressure - as an important safety limit of mechanical ventilation - is calculated using a formula:

    dP = Pplat - PEEP

    (Pplat: plateau pressure, PEEP: positive end-expiratory pressure)

  5. Postoperative Pulmonary Complications (PPCs)

    Time frame: From the end of surgery to 48 hours

    PPCs are defined as:

    • atelectasis detected on computed tomography or chest radiograph,
    • pneumonia,
    • Acute Respiratory Distress Syndrome,
    • pulmonary aspiration (clear clinical history AND radiological evidence) within 48 hours after surgery

Other outcomes

  1. Length of hospital stay

    Time frame: From the date of surgery until discharge, up to 28 days

    Length of hospital stay in days after surgery

  2. In-hospital mortality

    Time frame: From date of surgery until the date of death, up to 28 days

    Death occured during hospital stay after surgery

  3. 28-days mortality

    Time frame: 28 days after surgery

    Death occured during 28 days after surgery

  4. Adverse events related to the PEEP titrating procedure

    Time frame: During surgery

    Adverse Events (AEs) related to the PEEP titrating procedure are defined as: severe or prolonged hypotension (systolic blood pressure < 90 mmHg); significant cardiac arrhythmias

    Serious adverse events (SAEs) related to the PEEP titrating procedure are defined as: severe barotrauma leading to pneumothorax; significant prolongation of hospitalization; persistent or significant disability or incapacity; severe deterioration (life-threatening state or even death)

Study contacts

Contact information is provided by the study sponsor or research team.

Gergely Bokrétás, MD

CONTACT

[email protected]

Zoltán Ruszkai, MD, PhD

CONTACT

[email protected]

36-20-915-1978

Sponsors and collaborators

Lead sponsor

Pest County Flór Ferenc Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TITRANT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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