An interventional study of EIT-guided PEEP titration and Cdyn-guided PEEP titration in Mechanical Power, Postoperative Pulmonary Complications (PPCs) and Oxygenation, sponsored by Pest County Flór Ferenc Hospital. Recruiting at 3 sites in Hungary. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Pest County Flór Ferenc Hospital · Not applicable, Interventional, and Treatment
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:
Participants will:
The aim of this study is to compare the effects of two different - electrical impedance tomography guided (EIT) versus dynamic pulmonary compliance guided (Cdyn) - positive end-expiratory pressure (PEEP) titrating methods on mechanical power of ventilation (MP), oxygenation, respiratory mechanics parameters, global inhomogeneity index (GI), overdistension/collapse (ODCL) and postoperative pulmonary complications (PPCs) in patients with non-injured lungs undergoing laparoscopic gynecological surgery. Despite Cdyn-directed lung protective ventilation has several proven advantages, the investigators hypothesize that optimizing intraoperative mechanical ventilation using EIT may further improve patient outcomes by reducing MP responsible for ventilator induced lung injury (VILI) and consequent PPCs. These anticipated advantages may improve the knowledge about individualized intraoperative protective ventilation, enhance postoperative recovery, shorten in-hospital stay and reduce healthcare related costs.
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.
Pest County Flór Ferenc Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
EIT-guided PEEP titration procedure to achieve individually optimal level of PEEP
Procedure: EIT-guided PEEP titration
Cdyn-guided PEEP titration procedure to achieve individually optimal level of PEEP
Procedure: 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 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.
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.
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)
Time frame: During surgery
Oxygenation
Oxygenation indicated by the PaO2/FiO2 ratio
Time frame: From the beginning of surgery to 48 hours after surgery
Positive end-expiratory pressure (PEEP)
The level of individually optimal PEEP determined during a PEEP titration procedure
Time frame: During surgery
Dynamic pulmonary compliance (Cdyn)
Dynamic pulmonary compliance measured by the ventilator during mechanical ventilation
Time frame: During surgery
Driving pressure (dP)
Driving pressure - as an important safety limit of mechanical ventilation - is calculated using a formula: dP = Pplat - PEEP (Pplat: plateau pressure, PEEP: positive end-expiratory pressure)
Time frame: During surgery
Postoperative Pulmonary Complications (PPCs)
PPCs are defined as: 1. atelectasis detected on computed tomography or chest radiograph, 2. pneumonia, 3. Acute Respiratory Distress Syndrome, 4. pulmonary aspiration (clear clinical history AND radiological evidence) within 48 hours after surgery
Time frame: From the end of surgery to 48 hours
Length of hospital stay
Length of hospital stay in days after surgery
Time frame: From the date of surgery until discharge, up to 28 days
In-hospital mortality
Death occured during hospital stay after surgery
Time frame: From date of surgery until the date of death, up to 28 days
28-days mortality
Death occured during 28 days after surgery
Time frame: 28 days after surgery
Adverse events related to the PEEP titrating procedure
Adverse Events (AEs) related to the PEEP titrating procedure are defined as: severe or prolonged hypotension (systolic blood pressure \< 90 mmHg); significant cardiac arrhythmias Serious adverse events (SAEs) related to the PEEP titrating procedure are defined as: severe barotrauma leading to pneumothorax; significant prolongation of hospitalization; persistent or significant disability or incapacity; severe deterioration (life-threatening state or even death)
Time frame: During surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pest County Flór Ferenc Hospital