NCT07170514

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Nov 2025Oct 2027

First Submitted

Initial submission to the registry

August 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

August 29, 2025

Last Update Submit

April 9, 2026

Conditions

Mechanical PowerPostoperative Pulmonary Complications (PPCs)Oxygenation

Keywords

electrical impedance tomographydynamic pulmonary compliancepositive end-expiratory pressuremechanical powerpulmonary protective ventilationPao/FiO2postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

  • Mechanical Power (MP)

    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)

    During surgery

Secondary Outcomes (5)

  • Oxygenation

    From the beginning of surgery to 48 hours after surgery

  • Positive end-expiratory pressure (PEEP)

    During surgery

  • Dynamic pulmonary compliance (Cdyn)

    During surgery

  • Driving pressure (dP)

    During surgery

  • Postoperative Pulmonary Complications (PPCs)

    From the end of surgery to 48 hours

Other Outcomes (4)

  • Length of hospital stay

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

  • In-hospital mortality

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

  • 28-days mortality

    28 days after surgery

  • +1 more other outcomes

Study Arms (2)

EIT-GROUP

EXPERIMENTAL

EIT-guided PEEP titration procedure to achieve individually optimal level of PEEP

Procedure: EIT-guided PEEP titration

Cdyn-GROUP

ACTIVE COMPARATOR

Cdyn-guided PEEP titration procedure to achieve individually optimal level of PEEP

Procedure: Cdyn-guided PEEP titration

Interventions

Cdyn-guided PEEP titrationPROCEDURE

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.

Cdyn-GROUP
EIT-guided PEEP titrationPROCEDURE

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.

EIT-GROUP

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Semmelweis University

Budapest, Budapest, 1085, Hungary

NOT YET RECRUITING

Semmelweis Hospital Kiskunhalas

Kiskunhalas, Bács-Kiskun county, 6400, Hungary

NOT YET RECRUITING

Flór Ferenc Hospital Kistarcsa

Kistarcsa, Pest County, 2143, Hungary

RECRUITING

Study Officials

  • Zoltán Ruszkai, MD, PhD

    Flór Ferenc Hospital Kistarcsa

    STUDY DIRECTOR

Central Study Contacts

Zoltán Ruszkai, MD, PhD

CONTACT

36-20-915-1978ruszkai.zoltan@florhosp.hu

Gergely Bokrétás, MD

CONTACT

bokretas.gregely@florhosp.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Anesthesiology and Intensive Therapy

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 12, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

October 30, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

HU(3)