AzTrials
AzTrials

PneumoperitoneumCP-EITNCT06481124

End-expiratory Pressure During Laparoscopic Surgery in the Trendelenburg Position by Electrical Impedance Tomography

An observational study of Pneumoperitoneum and Trendelenburg Position, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pneumoperitoneum (PNP) and the position of the patient required for laparoscopic surgery lead to pathophysiological changes that complicate anesthesia. PNP is characterized by an increased intra-abdominal pressure (IAP), the cranial displacement of the diaphragm that can lead to the formation of intraoperative… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
electrical impedance tomography
Type of treatment
Medical device
How many people
50 participants
Where
1 siteRussia
Study dates
24 Jun 2024to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent elective gynecological operations in conditions of carboxyperitoneum with Trendelenburg position

Who may be able to join

  • Patients who undergo gynecological surgery under conditions of carboxyperitoneum in the Trendelenburg position.

Who cannot join

  • Pregnancy,
  • Hypoxemia before surgery (SpO2 < 94%),
  • body mass index more than 35 kg/m2,
  • Unstable hemodynamics and/or life-threatening arrhythmia,
  • Primary or secondary lung diseases (COPD, interstitial lung diseases, metastatic lung disease)
  • Presence of an implantable pacemaker and/or defibrillator
  • Chronic diseases in the stage of decompensation with the development of extrapulmonary organ dysfunction (liver cirrhosis, progression of cancer, chronic heart failure).

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Clinical Hospital 4, Sechenov University

    Moscow, 119048

Other trials in Russia

About this study

Official title: Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery in the Trendelenburg Position Based on Ventilation and Perfusion Measured by Electrical Impedance Tomography: the CP-EIT Observational Study

Pneumoperitoneum (PNP) and the position of the patient required for laparoscopic surgery lead to pathophysiological changes that complicate anesthesia. PNP is characterized by an increased intra-abdominal pressure (IAP), the cranial displacement of the diaphragm that can lead to the formation of intraoperative atelectasis and decrease end-expiratory lung volume (EELV). At the same time, PNP can reduce respiratory system compliance by 30-50% in healthy patients. During elective abdominal surgery under general anesthesia, atelectasis forms in almost 90% of patients and can become a focus of postoperative pneumonia. The negative effect of PNP is more prominent in Trendelenburg position. And one of the methods to avoid the effects of PNP and Trendelenburg position on lung tissue is to apply positive end-expiratory pressure (PEEP). PEEP is acknowledged as a component of lung protective ventilation (LPV) along with low tidal volume (TV) 6-8 ml/kg. On the other hand, excessive PEEP can lead to the overdistension of lung tissue and cause volutrauma and hemodynamic instability. It is necessary to use sufficient PEEP to minimize atelectasis, improve respiratory biomechanics and maintain oxygenation.

Electrical impedance tomography shows changes in ventilation and perfusion during mechanical ventilation with the different PEEP levels.

The study aimed to select optimum PEEP level based on optimum ventilation-to-perfusion match based on electrical impedance tomography measurements.

Read the detailed description

Electrical impedance tomography shows changes in ventilation and perfusion during mechanical ventilation with the different PEEP levels. The investigators will measure the following variables: resistivity of low and high pass band and end-expiratory lung index in 4 regions of interest and globally, global inhomogeneity index, global lung-heart index, global regional ventilation delay, compliance win, compliance loss, plateau pressure, and driving pressure.

The investigators will measure abovementioned variables in the following conditions:

  • PEEP 5 mbar with the patient in a horizontal supine position (initial measurement, Baseline),
  • PEEP 5 mbar in Trendelenburg position in carboxyperitoneum conditions (after reaching the set abdominal pressure of 12-14 mbar) (reference measurement, Ref),
  • PEEP 8 mbar in Trendelenburg position under carboxyperitoneum conditions (abdominal pressure 12-14 mbar),
  • PEEP 10 mbar in Trendelenburg position in carboxyperitoneum conditions (abdominal pressure 12-14 mbar),
  • PEEP 12 mbar in Trendelenburg position in carboxyperitoneum conditions (abdominal pressure 12-14 mbar),
  • PEEP 14 mbar in Trendelenburg position in carboxyperitoneum conditions (abdominal pressure 12-14 mbar),
  • PEEP 16 mbar in Trendelenburg position in carboxyperitoneum conditions (abdominal pressure 12-14 mbar)
  • PEEP 5 mbar with the patient in a horizontal supine position after deflation of the carboxyperitoneum.

After 5 minutes of carboxyperitoneum in Trendelenburg position the investigators will assess ventilation, perfusion and their relationship by the "Analysis" tab in comparison with the initial one in the intubated patient in the supine position (Baseline): improvement of ventilation (CW - compliance win, in %) and deterioration of ventilation (CL - compliance loss, in %), global homogeneity of ventilation (GI - homogeneity index, in %), regional ventilation delays (RVD, in %), ventilation compliance index and perfusion (LHI - lung heart index, in %).

After all stages have been completed, a comparative analysis of the influence of different levels of PEEP on ventilation, perfusion and their ratio will be carried out by using the "Analysis" tab at each stage in comparison with the reference (Ref): CW and CL, GI, RVD, LHI.

Being tested
electrical impedance tomography
Medical subject headings
Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electrical impedance tomographyDevice

    Measurement of ventilation and perfusion during mechanical ventilation with different positive end-expiratory pressure by electrical impedance tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimum positive end-expiratory pressure level by compliance win

    Positive end-expiratory pressure level selected by maximal compliance win measured by electrical impedance tomography

    Measured: 40 minutes

  2. Optimum positive end-expiratory pressure level by heart-lung index

    Positive end-expiratory pressure level selected by maximal heart-lung index measured by electrical impedance tomography

    Measured: 40 minutes

Secondary outcomes (10)

  1. Compliance win

    Increase in compliance measured by electrical impedance tomography in percent

    Measured: 3 minutes

  2. Compliance loss

    Decrease in compliance measured by electrical impedance tomography in percent

    Measured: 3 minutes

  3. Global inhomogeneity index

    Global inhomogeneity index measured by electrical impedance tomography in percent

    Measured: 3 minutes

  4. Regional ventilation delay

    Regional ventilation delay measured by electrical impedance tomography in percent

    Measured: 3 minutes

  5. Lung-heart index

    Lung-heart index measured by electrical impedance tomography in percent

    Measured: 3 minutes

  6. Resistivity of Low Pass Band

    Low pass band resistivity measured by electrical impedance tomography in Ohms*m

    Measured: 3 minutes

  7. Resistivity of High Pass Band

    High pass band resistivity measured by electrical impedance tomography in Ohms*m

    Measured: 3 minutes

  8. End-expiratory volume index change

    End-expiratory volume index change measured by electrical impedance tomography

    Measured: 3 minutes

  9. Plateau pressure

    Pressure measured in circuit during the inspiratory pause in mbar

    Measured: 3 minutes

  10. Driving pressure

    Difference between plateau pressure and positive end-expiratory pressure in mbar

    Measured: 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start24 Jun 2024
  3. Primary completion1 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481124
Sponsor's protocol ID
CP-EIT
Acronym
CP-EIT
Status last verified
Jun 2024
First submitted
18 Jun 2024
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Andersson LE, Baath M, Thorne A, Aspelin P, Odeberg-Wernerman S. Effect of carbon dioxide pneumoperitoneum on development of atelectasis during anesthesia, examined by spiral computed tomography. Anesthesiology. 2005 Feb;102(2):293-9. doi: 10.1097/00000542-200502000-00009.

    PubMed 15681942

  • Loring SH, Behazin N, Novero A, Novack V, Jones SB, O'Donnell CR, Talmor DS. Respiratory mechanical effects of surgical pneumoperitoneum in humans. J Appl Physiol (1985). 2014 Nov 1;117(9):1074-9. doi: 10.1152/japplphysiol.00552.2014. Epub 2014 Sep 11.

    PubMed 25213641

  • Barbosa FT, Castro AA, de Sousa-Rodrigues CF. Positive end-expiratory pressure (PEEP) during anaesthesia for prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.

    PubMed 24919591

  • Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

    PubMed 24283226

  • Fahy BG, Barnas GM, Nagle SE, Flowers JL, Njoku MJ, Agarwal M. Changes in lung and chest wall properties with abdominal insufflation of carbon dioxide are immediately reversible. Anesth Analg. 1996 Mar;82(3):501-5. doi: 10.1097/00000539-199603000-00013.

    PubMed 8623951

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumoperitoneum and Trendelenburg Position, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.

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 1 inclusion and 7 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: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimum positive end-expiratory pressure level by compliance win (time frame: 40 minutes). The study lists 2 primary outcomes in all. 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 NCT06481124, which also lists 5 linked publications.

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 2 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in