NCT07170514 EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery
| NCT ID | NCT07170514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pest County Flór Ferenc Hospital |
| Condition | Mechanical Power |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-11-10 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Zoltán Ruszkai, MD, PhD
STUDY DIRECTOR
Flór Ferenc Hospital Kistarcsa
Frequently Asked Questions
Who can join the NCT07170514 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Mechanical Power. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07170514 currently recruiting?
Yes, NCT07170514 is actively recruiting participants. Contact the research team at ruszkai.zoltan@florhosp.hu for enrollment information.
Where is the NCT07170514 trial being conducted?
This trial is being conducted at Budapest, Hungary, Kiskunhalas, Hungary, Kistarcsa, Hungary.
Who is sponsoring the NCT07170514 clinical trial?
NCT07170514 is sponsored by Pest County Flór Ferenc Hospital. The principal investigator is Zoltán Ruszkai, MD, PhD at Flór Ferenc Hospital Kistarcsa. The trial plans to enroll 200 participants.