N/A
Completed N=33
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
Source: ClinicalTrials.gov NCT04107493 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) — 91.2; 90.0 percentage of oxygen saturation
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) |
91.2; 90.0 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04107493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.