跳至主要内容
临床试验/NCT05953298
NCT05953298已完成不适用

Evaluation by Electrical Impedancemetry of the Variation of Lung Volumes Under NIV in Patients With COPD

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
End-Expiratory Lung Impedance (EELI) evolution during NIV sessions

研究概览

简要总结

The aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. The main objective is to evaluate the variation of End-expiratory lung volume (EELV) reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography during a 20 minutes NIV session.

详细描述

In patients with COPD, European recommendations recommend the use of NIV with a "high pressure" setting (1). These ventilatory modalities go against what is done in acute. Indeed, in this case, the pressures are much lower, because the risk of asynchronies and dynamic hyperinflation under NIV is then very important.

The usual techniques for evaluating lung volume and dynamic hyperinflation do not allow this to be measured under NIV.

Assessing lung volumes under NIV in stable COPD patients is therefore of major interest in understanding the impact of "high-intensity" ventilation.

Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level.(2) Among these measures, the End-Expiratory Lung Impedance (EELI), strongly correlated to the End-Expiratory Lung Volume (EELV), is the reflection of the FRC and can be dynamically monitored in real time at the patient's bedside(3). However, it has never been used in stable COPD patients on NIV, and could be an interesting tool for analyzing the impact of NIV on lung volumes.

The main objective is to evaluate the variation of EELV reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography, during a 20-minute session of NIV in patients with COPD at the stable state

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital;
  • Patient benefiting from social protection from the national health insurance fund;
  • Patient having read the patient information letter and given his non-objection to participate in the study.

排除标准

  • Obesity with a BMI > 35;
  • Respiratory exacerbation during treatment;
  • Patient with one or more contraindications to the implementation of EIT(7):
  • Pacemaker, defibrillator, electric active medical device;
  • Damaged skin condition, dressing on the observation area;
  • Risk related to fitting the belt (fracture, spinal lesions, etc.);
  • Uncontrollable movements;
  • Current electrotherapy;
  • Presence of a magnetic field (magnetic resonance imaging);
  • Other bioimpedance measurements in progress;
  • Pregnant woman ;
  • Tidal volume < 1ml/kg;
  • Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3);
  • Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision;
  • Patient included in other protocols that may interact with this study;

结局指标

主要结局

End-Expiratory Lung Impedance (EELI) evolution during NIV sessions

时间窗: Day 1

End-Expiratory Lung impedance is related to the End-Expiratory Lung Volume reflecting the functional residual capacity (FRC). It is obtained by electrical impedance tomography. EELI values are presented in arbitrary values (v.a) and can vary greatly between individuals. Thus, as previously proposed by (4), the EELI values during the different measurement phases will be assessed and presented as a percentage change from their reference value. The main objective of this study aims to observe the evolution of the EELI under NIV in stable COPD patients, the reference EELI value will be that measured at T1 (NIV initiation+1 minute), compared to that measured at T2 (NIV+20minutes) under the ∆EELI%T2 abbreviation from the following calculation: ∆EELI%T2 = (EELIT1-EELIT2)/EELIT1\*100

次要结局

  • Transcutaneous capnia(Day 1)
  • End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions(Day 1)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验