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临床试验/NCT03835741
NCT03835741终止不适用

Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

Laval University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年12月17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
17
试验地点
2
主要终点
Hospital length of stay

研究概览

简要总结

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

详细描述

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.

Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm).

The impact on the hospital length of stay will be evaluated.

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
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

  • COPD or suspected COPD ( Age>40, active or smoking history > 10pack/years), -
  • Acute exacerbation (increasing dyspnea recently)
  • One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea,
  • Moderate oxygen therapy: Oxygen flow < 8 lpm (or FiO2 < 0.60) to maintain a SpO2 >or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 > or = 92%)

排除标准

  • Patient refusal
  • COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose
  • No SpO2 signal
  • Encephalopathy score > 2
  • Other respiratory support needed (intubation or NIV)
  • Patient on withdrawal life support
  • Advance neoplasia (palliative stage) or terminal respiratory distress
  • Unavailability of FreeO2 device at the randomisation
  • Non optimal patient collaboration

结局指标

主要结局

Hospital length of stay

时间窗: From hospital admission until hospital discharge (around one week expected)

Duration of the hospital length of stay

次要结局

  • Non invasive or invasive mechanic ventilation rate use(During hospital stay: from hospital admission until hospital discharge (around one week expected))
  • ICU transfer(During hospital stay : from hospital admission until hospital discharge (around one week expected))
  • Oxygen administration duration(During hospital stay : from hospital admission until hospital discharge (around one week expected))

研究者

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

François Lellouche

Principal Investigator

Laval University

研究点 (2)

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