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临床试验/NCT02068911
NCT02068911已完成不适用

Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

Centre d'Investigation Clinique et Technologique 8051 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
concordance between the nocturnal average values of ETCO2 and PTCO2

研究概览

简要总结

The purpose of this study is to compare the measure of the CO2 obtained on the end-tidal expiratory gas (ETCO2) with the value of CO2 obtained by transcutaneous measure (PTCO2), in home-ventilated neuromuscular patients.

详细描述

Monitoring of the effectiveness of ventilation in patients with neuromuscular require to regularly measure blood gases and in particular carbon dioxide (CO2). The reference technique is arterial puncture. In recent years, a non-invasive techniques measuring CO2 by transcutaneous sensor (PTCO2) was introduced among the tools regularly used for follow-up monitoring of home ventilated patients.

Another technique for monitoring CO2, originally developed for anesthesia, is based on the measurement of exhaled CO2 (ETCO2). This technique requires relatively simple equipment, and represents a potential alternative for monitoring home-ventilated patients.

Recently, sensors for ETCO2 were coupled to devices for home ventilation. To the best of our knowledge, the role of ETCO2 in monitoring long-term ventilated patients has not been investigated to date.

The purpose of the study is to analyze the correlation between the two non-invasive methods for measuring CO2: PTCO2 and ETCO2, in a group of home-ventilated patients with neuromuscular disease.

The patients will be recruited during a routine follow-up hospitalization for their home-ventilation, and the ETCO2 will be measured during one night, in addition to the routinely measured PTCO2.

研究设计

研究类型
Observational
时间视角
Prospective

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

  • Patient with neuromuscular disease, treated with home invasive or non-invasive ventilation
  • Male or female age higher or equal to 18 years
  • Negative pregnancy test for women of childbearing age or having an effective contraception

排除标准

  • Acute Respiratory Failure
  • Long-term oxygen therapy
  • Refusal to participate in the study
  • Plan of legal protection
  • Pregnant Women
  • Failure to cooperate
  • No affiliation to a social security scheme

结局指标

主要结局

concordance between the nocturnal average values of ETCO2 and PTCO2

时间窗: one night

concordance between the nocturnal average values of the CO2 measured by the two non-invasive techniques ETCO2 and PTCO2

次要结局

  • concordance between the variation of the values of ETCO2 and PTCO2(one night)
  • concordance between the nocturnal maximal values of ETCO2 and PTCO2(one night)
  • concordance between the values of ETCO2, PTCO2 and arterial CO2 (PaCO2) measured at the same time(one night)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (1)

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