EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery (NCT07170514) | Clinical Trial Compass
RecruitingNot Applicable
EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery
Hungary200 participantsStarted 2025-11-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.