Portable Oxygen Concentrator in Non-hospitalized Patients With Chronic Heart Failure: A Proof-of-concept Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Inogen Inc.
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Heart rate
研究概览
简要总结
This is a one-day, proof-of-concept, pilot study of portable oxygen concentrator (POC) administration and Six Minute Walk Test (6MWT) distance in patients with stable chronic heart failure.
详细描述
This is a one-day, proof-of-concept, pilot study of portable oxygen concentrator (POC) administration and Six Minute Walk Test (6MWT) distance in patients with stable chronic heart failure. A total of 20 patients will be enrolled and undergo two 6MWT on the same day, with Inogen Rove 6 POC turned ON and turned OFF. They will be randomly assigned in a 1:1 ratio to either perform the first 6MWT with Inogen Rove 6 POC turned ON and the second 6MWT with Inogen Rove 6 POC turned OFF, or vice-versa (first and second 6MWT with Inogen Rove 6 POC turned OFF and turned ON, respectively).
Study Description: This is a one-day, proof-of-concept, pilot study of portable oxygen concentrator (POC) administration and Six Minute Walk Test (6MWT) distance in patients with stable chronic heart failure. A total of 20 patients will be enrolled and undergo two 6MWT on the same day, with Inogen Rove 6 POC turned ON and turned OFF. They will be randomly assigned in a 1:1 ratio to either perform the first 6MWT with Inogen Rove 6POC turned ON and the second 6MWT with Inogen Rove 6 POC turned OFF, or vice-versa (first and second 6MWT with Inogen Rove 6 POC turned OFF and turned ON, respectively).
On the day of the only study visit, informed consent will be obtained, inclusion/exclusion criteria will be assessed, and the following information will be obtained: patient demographics, cardiovascular medical history (including heart failure history), NYHA score, heart failure history, respiratory condition history, smoking history, review of current heart failure medications and other cardiovascular concomitant medications.
Eligible patients will be randomly assigned (in a 1:1 ratio) to one of the following 2 sequences:
- first 6MWT with Inogen Rove 6 POC turned ON followed by a second 6MWT with the Inogen Rove 6 POC turned OFF, or
- first 6MWT with the Inogen Rove 6 POC turned OFF, followed by a second 6MWT with the Inogen Rove 6 POC turned ON.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
All patients will have the nasal cannula in place during both 6MWTs, but the POC will be activated only during the test conducted with oxygen supplementation
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
- •Adult male or female
- •Diagnosed with chronic stable heart failure
- •NYHA functional class II to ambulatory class IV
- •Peripheral oxygen saturation on fingertip pulse oximetry (SpO2) ≤96% at rest
- •Willingness and ability to use a POC and with no allergy to cannula material
- •Patient with the capacity to provide informed consent
排除标准
- •Contraindication to the use of POC
- •Patient currently hospitalized or requiring hospitalization
- •Current acute decompensated HF requiring augmented therapy with vasodilator agents, and/or inotropic drugs, and/or augmented therapy or i.v. therapy with diuretics
- •History of acute coronary syndrome (unstable angina or myocardial infarction) within 3 months prior to study enrollment
- •Patient unable to walk
- •Patient who should be excluded in the opinion of the investigator
- •Participation in another interventional clinical trial within 30 days of signing the Information and Consent Form (ICF)
- •Pregnant female patient
结局指标
主要结局
Heart rate
时间窗: At 9 minutes (3 minutes after the end of the 6MWT)
Heart rate
Modified Borg Scale
时间窗: At 9 minutes (3 minutes after the end of the 6MWT)
Borg CR10 Scale (modified Borg Dyspnoea Scale). Scale with 0-10 scoring, where 0 means no Exertion and 10 means Maximal Exertion.
Walking distance during the 6MWT
时间窗: 6 minutes
Walking distance during the 6MWT
Oxygen saturation
时间窗: At 9 minutes (3 minutes after the end of the 6MWT)
Oxygen saturation on fingertip pulse oximetry
次要结局
- Adverse Events(Study period of approximately 5 hour on study day.)
- Tolerance to POC(6 minutes)