Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 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).
研究组 & 干预措施
Portable oxygen cylinder
Continuous flow oxygen cylinders will be used as a comparison.
干预措施: Portable Oxygen Cylinder (Device)
Mobi™ Portable Oxygen Concentrator
Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments
干预措施: Mobi (Device)
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