Mechanical PowerTITRANTNCT07170514
EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery
A study testing EIT-guided PEEP titration and Cdyn-guided PEEP titration in people with Mechanical Power and Postoperative Pulmonary Complications (PPCs), run by Pest County Flór Ferenc Hospital at 3 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mechanical Power, Postoperative Pulmonary Complications (PPCs), Oxygenation
- What is being tested?
- EIT-guided PEEP titration and Cdyn-guided PEEP titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesHungary
- Study dates
- 10 Nov 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for elective laparoscopic gynaecological surgery
- Age > 18 years
- Signed consent to participate in the trial
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gergely Bokrétás, MD contact
Hungary3 sites, 3 recruiting
- Not yet recruiting
Semmelweis University
Budapest, Budapest, 1085
Zsolt Molnár, MD, PhD, +36 30 302 6668, molnar.zsolt1@semmelweis.hu
Zsolt Molnár, MD, PhD
- Not yet recruiting
Semmelweis Hospital Kiskunhalas
Kiskunhalas, Bács-Kiskun county, 6400
András Lovas, MD, PhD, +36 20 465 8580, anlovas@gmail.com
András Lovas, MD, PhD
- Recruiting
Flór Ferenc Hospital Kistarcsa
Kistarcsa, Pest County, 2143
Zoltán Ruszkai, MD, PhD, +36 20 915 1978, ruszkai.zoltan@florhosp.hu
Gergely Bokrétás, MD, bokretas.gergely@florhosp.hu
About this study
Official title: Electrical Impedance Tomography vs Dynamic Compliance Guided Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery: A Multi-center, Prospective Randomized Trial - TITRANT
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.
Read more
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.
Read the detailed description
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.
- Being tested
- EIT-guided PEEP titration, Cdyn-guided PEEP titration
- Keywords
- electrical impedance tomography, dynamic pulmonary compliance, positive end-expiratory pressure, mechanical power, pulmonary protective ventilation, Pao/FiO2, postoperative pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-guided PEEP titrationProcedure or surgery
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 titrationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EIT-GROUP | Experimental | EIT-guided PEEP titration procedure to achieve individually optimal level of PEEP Receives: Procedure: EIT-guided PEEP titration |
| Cdyn-GROUP | Active comparator | Cdyn-guided PEEP titration procedure to achieve individually optimal level of PEEP Receives: Procedure: Cdyn-guided PEEP titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During surgery
Secondary outcomes (5)
Oxygenation
Oxygenation indicated by the PaO2/FiO2 ratio
Measured: 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
Measured: During surgery
Dynamic pulmonary compliance (Cdyn)
Dynamic pulmonary compliance measured by the ventilator during mechanical ventilation
Measured: 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)
Measured: During surgery
Postoperative Pulmonary Complications (PPCs)
PPCs are defined as:
- atelectasis detected on computed tomography or chest radiograph,
- pneumonia,
- Acute Respiratory Distress Syndrome,
- pulmonary aspiration (clear clinical history AND radiological evidence) within 48 hours after surgery
Measured: From the end of surgery to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start10 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical PowerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pest County Flór Ferenc Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged, Semmelweis University
- Responsible party
- Principal investigator, Zoltan Ruszkai, MD, PhD, Pest County Flór Ferenc Hospital
- Investigators
- Zoltán Ruszkai, MD, PhD, Study director, Flór Ferenc Hospital Kistarcsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170514
- Sponsor's protocol ID
- NNGYK/21074-6/2025
- Other IDs
- 1006
- Acronym
- TITRANT
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gered C, Szigetvary C, Miko A, Bokretas GP, Lovas A, Forgacs R, Nemes M, Molnar Z, Ruszkai Z. ElecTrical Impedance TomogRaphy vs dynamic compliANce guided positive end-expiratory pressure Titration during laparoscopic gynaecological surgery (TITRANT): protocol for a multicentre randomised trial. BMJ Open. 2026 Jun 17;16(6):e117631. doi: 10.1136/bmjopen-2026-117631.
PubMed 42309662
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography vs Dynamic Compliance Guided Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery: A Multi-center, Prospective Randomized Trial - TITRANT
- ClinicalTrials.gov ID
- NCT07170514
- Acronym / sponsor ID
- TITRANT / NNGYK/21074-6/2025
- Keywords
- electrical impedance tomography, dynamic pulmonary compliance, positive end-expiratory pressure, mechanical power, pulmonary protective ventilation, Pao/FiO2, postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pest County Flór Ferenc HospitalUniversity, hospital or other
- Collaborators
- Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged, Semmelweis University
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-GROUP | Experimental | Procedure: EIT-guided PEEP titrationEIT-guided PEEP titration procedure to achieve individually optimal level of PEEP |
| Cdyn-GROUP | Active comparator | Procedure: Cdyn-guided PEEP titrationCdyn-guided PEEP titration procedure to achieve individually optimal level of PEEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for elective laparoscopic gynaecological surgery
- Age > 18 years
- Signed consent to participate in the trial
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT-guided PEEP titrationDuring 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. | Procedure or surgery | EIT-GROUP |
| Cdyn-guided PEEP titrationDuring 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. | Procedure or surgery | Cdyn-GROUP |
Primary outcome
Mechanical Power (MP)
Time frame: During surgery
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)
5 secondary outcomes
Oxygenation
Time frame: From the beginning of surgery to 48 hours after surgery
Positive end-expiratory pressure (PEEP)
Time frame: During surgery
Dynamic pulmonary compliance (Cdyn)
Time frame: During surgery
Driving pressure (dP)
Time frame: During surgery
Postoperative Pulmonary Complications (PPCs)
Time frame: From the end of surgery to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Derived from this study: PubMed 42309662Gered C, Szigetvary C, Miko A, Bokretas GP, Lovas A, Forgacs R, Nemes M, Molnar Z, Ruszkai Z. ElecTrical Impedance TomogRaphy vs dynamic compliANce guided positive end-expiratory pressure Titration during laparoscopic gynaecological surgery (TITRANT): protocol for a multicentre randomised trial. BMJ Open. 2026 Jun 17;16(6):e117631. doi: 10.1136/bmjopen-2026-117631.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gergely Bokrétás, MD contact
Zoltán Ruszkai, MD, PhD study director
Flór Ferenc Hospital Kistarcsa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-guided PEEP titration and Cdyn-guided PEEP titration in people with Mechanical Power and Postoperative Pulmonary Complications (PPCs), run by Pest County Flór Ferenc Hospital at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoltán Ruszkai, MD, PhD (36-20-915-1978, ruszkai.zoltan@florhosp.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Power (MP) (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07170514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.