Actively Recruiting
Electrical Impedance Tomography vs Dynamic Compliance Guided Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery: A Multi-center, Prospective Randomized Trial - TITRANT
Led by Pest County Flór Ferenc Hospital · Updated on 2026-04-14
200
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
P
Pest County Flór Ferenc Hospital
Lead Sponsor
K
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two methods of setting positive end-expiratory pressure (PEEP) during mechanical ventilation in patients with healthy lungs undergoing laparoscopic gynecological surgery. The study evaluates whether electrical impedance tomography (EIT)-guided PEEP titration can better protect the lungs by reducing the mechanical power of ventilation and improving oxygen levels compared to the dynamic pulmonary compliance (Cdyn)-guided method. The goal is to see if EIT guidance can reduce lung injury, postoperative lung complications, and improve recovery while potentially lowering healthcare costs. Two groups will be studied: one receiving PEEP titration guided by EIT and the other guided by Cdyn. PEEP will be decreased stepwise from 18 to 6 cmH2O during surgery with measurements taken at each level. The optimal PEEP is determined differently for each group based on either EIT parameters or Cdyn values. After determining optimal PEEP, lung protective ventilation with low tidal volumes will be used during surgery. Participants will be monitored during surgery and for two days after for ventilation power, oxygenation, lung function, and lung complications. Assessments include blood gas analyses, lung imaging with EIT, and clinical scoring of organ function. Mortality will be followed up to 28 days after surgery. This thorough monitoring aims to understand how each method affects lung protection and recovery after surgery.
CONDITIONS
Brief Title
EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient scheduled for elective laparoscopic gynaecological surgery
- Age > 18 years
- Signed consent to participate in the trial
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery
Participants undergo individualized PEEP titration during laparoscopic gynecological surgery using either electrical impedance tomography (EIT) or dynamic pulmonary compliance (Cdyn) guidance to determine optimal ventilation settings, followed by lung protective mechanical ventilation during surgery.
1 intraoperative visit (in-person) with measurements recorded every 15 to 30 minutes during surgery
Duration - 48 hours post-surgery with mortality follow-up until 28 days
Participants have postoperative assessments including oxygenation monitoring, arterial blood gas sampling, EIT measurements for lung condition, and clinical evaluations during the first two days after surgery, with mortality follow-up until 28 days after surgery.
Multiple visits including assessments immediately after extubation and at 30 minutes, 2, 6, 12, 24, and 48 hours after surgery
Trial Site Locations
Total: 3 locations
1
Semmelweis University
Budapest, Budapest, Hungary, 1085
Not Yet Recruiting
2
Semmelweis Hospital Kiskunhalas
Kiskunhalas, Bács-Kiskun county, Hungary, 6400
Not Yet Recruiting
3
Flór Ferenc Hospital Kistarcsa
Kistarcsa, Pest County, Hungary, 2143
Actively Recruiting
Research Team
Z
Zoltán Ruszkai, MD, PhD
G
Gergely Bokrétás, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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