EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery
NCT ID: NCT07170514
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-10-01
2027-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PEEP Titration Guided by Electrical Impedance Tomography in Laparoscopic Surgery The PEaRL Study
NCT07289113
Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography
NCT04174014
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
NCT03704038
Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children
NCT07319624
Combining Electrical Impedance Tomography and Thoracic Ultrasound Toinvestigate Dynamic Changes
NCT06958770
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EIT-GROUP
EIT-guided PEEP titration procedure to achieve individually optimal level of PEEP
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.
Cdyn-GROUP
Cdyn-guided PEEP titration procedure to achieve individually optimal level of PEEP
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \> 18 years
* Signed consent to participate in the trial
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
OTHER_GOV
Semmelweis University
OTHER
Pest County Flór Ferenc Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zoltan Ruszkai, MD, PhD
Head of Department of Anesthesiology and Intensive Therapy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zoltán Ruszkai, MD, PhD
Role: STUDY_DIRECTOR
Flór Ferenc Hospital Kistarcsa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Semmelweis Hospital Kiskunhalas
Kiskunhalas, Bács-Kiskun county, Hungary
Flór Ferenc Hospital Kistarcsa
Kistarcsa, Pest County, Hungary
Semmelweis University
Budapest, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BM/8893-3/2025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.