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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107493
• Other study ID #: MA-19-03-02
• Status: Completed
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: May 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Portable Oxygen Cylinder
A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
• Mobi
ResMed's variant of POC

Locations

Country	Name	City	State
United States	SleepData	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gloeckl R, Jarosch I, Schneeberger T, Fiedler C, Lausen M, Weingaertner J, Hitzl W, Kenn K, Koczulla AR. Comparison of supplemental oxygen delivery by continuous versus demand based flow systems in hypoxemic COPD patients - A randomized, single-blinded cross-over study. Respir Med. 2019 Sep;156:26-32. doi: 10.1016/j.rmed.2019.08.001. Epub 2019 Aug 5. — View Citation

Güell Rous R. Long-term oxygen therapy: are we prescribing appropriately? Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7. Review. — View Citation

Outcome

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