Trial Outcomes & Findings for Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN) (NCT NCT04107493)
NCT ID: NCT04107493
Last Updated: 2021-05-26
Results Overview
Each subject's SpO2 will be measured when each subject takes six minutes walk test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Mean Sp02, measured during 6 minute walk test
Results posted on
2021-05-26
Participant Flow
Participants acted as their own controls. Participants were randomised as to the order they used the devices during the 6-minute walking test. There was a one hour wash out period between tests
Participant milestones
| Measure |
Portable Oxygen Cylinder, Then Mobi
Participants acted as their own control in this study.
Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC
Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
|
Mobi, Then Portable Oxygen Cylinder
Participants acted as their own control in this study.
Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC
Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
|
|---|---|---|
|
First Intervention (1 Hour)
STARTED
|
16
|
17
|
|
First Intervention (1 Hour)
COMPLETED
|
16
|
17
|
|
First Intervention (1 Hour)
NOT COMPLETED
|
0
|
0
|
|
Washout (One Hour)
STARTED
|
16
|
17
|
|
Washout (One Hour)
COMPLETED
|
16
|
17
|
|
Washout (One Hour)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
16
|
17
|
|
Second Intervention
COMPLETED
|
16
|
17
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=33 Participants
Participants acted as their own control during this study. Participants used a portable oxygen cylinder whilst doing a 6 minute walking test. After a wash out period the participants completed the 6 minute walking test with the second portable oxygen cylinder. The order of the oxygen cylinders (mobi or standard) was randomised
|
|---|---|
|
Age, Continuous
|
69.86 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mean Sp02, measured during 6 minute walk testEach subject's SpO2 will be measured when each subject takes six minutes walk test
Outcome measures
| Measure |
Portable Oxygen Cylinder
n=33 Participants
Continuous flow oxygen cylinders will be used as a comparison.
Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
|
Mobi™ Portable Oxygen Concentrator
n=33 Participants
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
Mobi: ResMed's variant of POC
|
|---|---|---|
|
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
|
91.2 percentage of oxygen saturation
Standard Error 0.7
|
90.0 percentage of oxygen saturation
Standard Error 0.7
|
Adverse Events
Standard Oxygen Cylinder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobi
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place