Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
Not Applicable
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT04107493
- Lead Sponsor
- ResMed
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) Mean Sp02, measured during 6 minute walk test Each subject's SpO2 will be measured when each subject takes six minutes walk test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SleepData
🇺🇸San Diego, California, United States
SleepData🇺🇸San Diego, California, United States