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NCT Number: NCT06481124

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinical Hospital 4, Sechenov University

Moscow, 119048, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

electrical impedance tomography

Device

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

Primary outcomes

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

    Time frame: 40 minutes

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

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

    Time frame: 40 minutes

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

Secondary outcomes

  1. Compliance win

    Time frame: 3 minutes

    Increase in compliance measured by electrical impedance tomography in percent

  2. Compliance loss

    Time frame: 3 minutes

    Decrease in compliance measured by electrical impedance tomography in percent

  3. Global inhomogeneity index

    Time frame: 3 minutes

    Global inhomogeneity index measured by electrical impedance tomography in percent

  4. Regional ventilation delay

    Time frame: 3 minutes

    Regional ventilation delay measured by electrical impedance tomography in percent

  5. Lung-heart index

    Time frame: 3 minutes

    Lung-heart index measured by electrical impedance tomography in percent

  6. Resistivity of Low Pass Band

    Time frame: 3 minutes

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

  7. Resistivity of High Pass Band

    Time frame: 3 minutes

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

  8. End-expiratory volume index change

    Time frame: 3 minutes

    End-expiratory volume index change measured by electrical impedance tomography

  9. Plateau pressure

    Time frame: 3 minutes

    Pressure measured in circuit during the inspiratory pause in mbar

  10. Driving pressure

    Time frame: 3 minutes

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

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study 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

Acronym: CP-EIT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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