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临床试验/NCT03811158
NCT03811158终止不适用

The Diaphragm Activity Level and Cardiopulmonary Function Between Heated Humidified High-Flow Nasal Cannula and Unheated Humidified High-Flow Oxygen Mask in Acute Exacerbation of COPD Patients as Post-Extubation Respiratory Support

Fu Jen Catholic University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Diaphragm electrical activity

研究概览

简要总结

Patients with COPD exacerbation usually need respiratory support after extubation. Recently, HHHFNC has been used in both adult and neonates with post-extubation respiratory support. Studies indicate that HHHFNC has seminar efficacy compared to non-invasive positive pressure ventilation and superior than conventional oxygen therapy. There are no clinical data of diaphragm electrical activity and cardiopulmonary function for using HHHFNC and UHFOM as post-extubation respiratory support.

详细描述

Objectives: The aim of this study is to compare the Edi level and cardiopulmonary parameters between heated humidified high-flow nasal cannula (HHHFNC) versus unheated high-flow oxygen mask (UHFOM) in acute exacerbation of chronic obstructive pulmonary disease (COPD) patients with post-extubation respiratory support. This is the first clinical trial to investigate and analysis the variations of cardiopulmonary parameters and Edi level between HHHFNC and UHFOM in adult patients.

研究设计

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

盲法说明

All data will be decoded before biostatics analysis

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

  • AE of COPD received intubation and ready to be weaning
  • P/F ratio > 200 during SBT before extubation

排除标准

  • Unable to insert NG tube
  • Refuse to re-intubated when respiratory failure after extubation
  • Planned NIV use after extubation

结局指标

主要结局

Diaphragm electrical activity

时间窗: 2 days

In voltage

次要结局

  • Cardiac index(2 days)
  • PtcO2 & PtcCO2(2 days)
  • Re-intubation rate(2 days)
  • ICU stay(through study completion, an average 1 months)
  • Hospital stay(through study completion, an average 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

研究点 (2)

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