NCT02552732终止不适用
Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
Fisher and Paykel Healthcare2 个研究点 分布在 2 个国家目标入组 29 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- NHF Use for 30 Days Following Discharge After AECOPD
研究概览
简要总结
The aim of this feasibility study is to provide data for a subsequent randomized controlled trial to investigate if patient outcomes will be improved after an acute COPD exacerbation using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility study will investigate the following: process, resources, management and scientific aspects of delivering NHF as an adjunct therapy in COPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •18 years of age or older
- •Male and female
- •Admitted to the respiratory ward(s) of either recruiting hospitals with AECOPD as the primary diagnostic reason for admission.
排除标准
- •Given a new home oxygen therapy prescription during the current hospital admission
- •The investigator believes the participant or their care giver will be unable to safely use the myAIRVO 2 device following discharge
- •They have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
研究组 & 干预措施
NHF with or without Oxygen
Experimental
NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge
干预措施: NHF with or without Oxygen (Device)
结局指标
主要结局
NHF Use for 30 Days Following Discharge After AECOPD
时间窗: 30 days after hospital discharge
Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring
次要结局
- Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting(30 days after hospital discharge)
- Average Use Per Day of the myAIRVO 2 During Week 3(Third week after hospital discharge)
- Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home(30 days after hospital discharge)
- Average Use Per Day of the myAIRVO 2 During Week 1(First week after hospital discharge)
- Average Use Per Day of the myAIRVO 2 During Week 2(Second week after hospital discharge)
- Average Use Per Day of the myAIRVO 2 During Week 4(Fourth week after hospital discharge)
- Average Use Per Day on Days of myAIRVO 2 Use(30 days after hospital discharge)
- Number of Participants Using Home Oxygen(At study entry)
- Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow(30 days after hospital discharge)
- Number of Participants Who Where Screened But Were Excluded From Enrollment(30 days after hospital discharge)
- Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge(30 days after hospital discharge)
- In Those That Had at Least One Hospital Readmission: Hospital Readmission Length(30 days after hospital discharge)
- Number of Participants With at Least One GP Visit Within 30 Days of Discharge(30 days after hospital discharge)
- SVC(in) at Day 1 and 31(1st and 31st day after hospital discharge)
- Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days(At study completion)
- Reason for ED Visits(30 days after hospital discharge)
- FEV1 at Day 1 and 31(1st and 31st day after hospital discharge)
- Reasons for Hospital Admissions(30 days after hospital discharge)
- In Those That Had at Least One Hospital Readmission: Number of Readmissions(30 days after hospital discharge)
- Number of Participants With at Least One ED Visit Within 30 Days of Discharge(30 days after hospital discharge)
- In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission(30 days after hospital discharge)
- LACE Index for Hospital Admissions(30 days after hospital discharge)
- FVC Change From Day 1 to Day 31(1st and 31st day after hospital discharge)
研究者
研究点 (2)
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