NCT04107493已完成不适用
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
研究概览
简要总结
Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female, age ≥ 18 years at the time of signing informed consent.
- •Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
- •Current prescription for long-term oxygen therapy.
- •Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise.
- •Participants who can read and comprehend English.
排除标准
- •Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
- •Current oxygen therapy prescription for >5 L/min continuous flow.
- •Known or suspected contraindication for pulse-dose oxygen.
- •Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
- •Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
结局指标
主要结局
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
时间窗: Mean Sp02, measured during 6 minute walk test
Each subject's SpO2 will be measured when each subject takes six minutes walk test
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Portable Oxygen Concentrator (POC) Versus Standard of Care in Long-COVID: Randomized Crossover Exploratory Pilot Study.COVID-19NCT05212831Inogen Inc.21
已完成
不适用
Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen ConcentratorsCOPDNCT01673685The Queen Elizabeth Hospital32
已完成
不适用
Portable Oxygen Concentrator in Non-hospitalized Patients With Chronic Heart FailureHeart FailureNCT05719363Inogen Inc.20
已完成
不适用
Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung DiseaseChronic Obstructive Lung DiseasePulmonary FibrosisNCT01653730Ottawa Hospital Research Institute24
终止
不适用
Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)COPDNCT03513068ResMed108