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Идёт набор NCT07170514

EIT vs Dynamic Compliance Guided PEEP Titration During Laparoscopic Gynecological Surgery

Без фазы С лечением Mechanical Power Postoperative Pulmonary Complications (PPCs) Oxygenation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: EIT-guided PEEP titration, Cdyn-guided PEEP titration.
Кому может быть актуально
Состояния в реестре: Mechanical Power, Postoperative Pulmonary Complications (PPCs), Oxygenation. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Венгрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Electrical Impedance Tomography vs Dynamic Compliance Guided Positive End-expiratory Pressure Titration During Laparoscopic Gynecological Surgery: A Multi-center, Prospective Randomized Trial - TITRANT

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура EIT-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.
  • Процедура 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 Cdyn-GROUP optimal PEEP is considered as the PEEP value resulting the highest possible Cdyn measured by the ventilator.

Первичные конечные точки

  • Mechanical Power (MP) [Срок оценки: During surgery]
Вторичные конечные точки (5)
  • Oxygenation [Срок оценки: From the beginning of surgery to 48 hours after surgery]
  • Positive end-expiratory pressure (PEEP) [Срок оценки: During surgery]
  • Dynamic pulmonary compliance (Cdyn) [Срок оценки: During surgery]
  • Driving pressure (dP) [Срок оценки: During surgery]
  • Postoperative Pulmonary Complications (PPCs) [Срок оценки: From the end of surgery to 48 hours]

Критерии участия

Критерии включения

  • Patient scheduled for elective laparoscopic gynaecological surgery
  • Age > 18 years
  • Signed consent to participate in the trial

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Венгрия · 3 центра
  • Semmelweis University — Budapest
  • Semmelweis Hospital Kiskunhalas — Kiskunhalas
  • Flór Ferenc Hospital Kistarcsa — Kistarcsa

Публикации

  • 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. PMID 42309662

Идентификаторы

NCT: NCT07170514 · NNGYK/21074-6/2025 · 1006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗