跳至主要内容
临床试验/NCT07170514
NCT07170514招募中不适用

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

Pest County Flór Ferenc Hospital4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
4
主要终点
Mechanical Power (MP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

EIT-GROUP

Experimental

EIT-guided PEEP titration procedure to achieve individually optimal level of PEEP

干预措施: EIT-guided PEEP titration (Procedure)

Cdyn-GROUP

Active Comparator

Cdyn-guided PEEP titration procedure to achieve individually optimal level of PEEP

干预措施: Cdyn-guided PEEP titration (Procedure)

结局指标

主要结局

Mechanical Power (MP)

时间窗: 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)

Mechanical Power (MP)

时间窗: 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)

次要结局

  • Oxygenation(From the beginning of surgery to 48 hours after surgery)
  • Positive end-expiratory pressure (PEEP)(During surgery)
  • Driving pressure (dP)(During surgery)
  • Postoperative Pulmonary Complications (PPCs)(From the end of surgery to 48 hours)
  • Oxygenation(From the beginning of surgery to 48 hours after surgery)
  • Positive end-expiratory pressure (PEEP)(During surgery)
  • Dynamic pulmonary compliance (Cdyn)(During surgery)
  • Driving pressure (dP)(During surgery)
  • Postoperative Pulmonary Complications (PPCs)(From the end of surgery to 48 hours)

研究者

发起方
Pest County Flór Ferenc Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zoltan Ruszkai, MD, PhD

Head of Department of Anesthesiology and Intensive Therapy

Pest County Flór Ferenc Hospital

研究点 (4)

Loading locations...

相似试验