Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)

May 24, 2021 updated by: ResMed
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • SleepData

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Male or female, age ≥ 18 years at the time of signing informed consent.
  3. Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
  4. Current prescription for long-term oxygen therapy.
  5. 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.
  6. Participants who can read and comprehend English.

Exclusion Criteria:

  1. Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
  2. Current oxygen therapy prescription for >5 L/min continuous flow.
  3. Known or suspected contraindication for pulse-dose oxygen.
  4. Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
  5. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Portable oxygen cylinder
Continuous flow oxygen cylinders will be used as a comparison.
Device: Portable Oxygen Cylinder
A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
Other Names:
  • POC
Experimental: 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
Device: Mobi
ResMed's variant of POC
Other Names:
  • Mobi POC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
Time Frame: Mean Sp02, measured during 6 minute walk test
Each subject's SpO2 will be measured when each subject takes six minutes walk test
Mean Sp02, measured during 6 minute walk test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: Samuel Clark, M.D, SleepData

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2019

Primary Completion (Actual)

March 9, 2020

Study Completion (Actual)

March 9, 2020

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-19-03-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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