Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04170062 |
| Other study ID # |
IRB00206318 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is meant to compare the amount of oxygen required for hypoxemia relief between
current standard of care (oxygen only) and oxygen with the addition of high flow air for
Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), and Pulmonary
Hypertension (PH) patients during rest. Subjects will be titrated from 0 L/min until they
maintain 95% SpO2 for each of the following delivery methods:
1. Pulses of pure oxygen (control)
2. Constant high flow air with pulses of pure oxygen
3. Out of phase pulses of high flow air and pure oxygen
Description:
Each participant will require (1) visit, which will last approximately 4-5 hours.
At start of visit:
1. Vitals are taken (temperature, heart rate, SpO2, respiration rate, blood pressure, Borg
dyspnea score, Mmrc score) while participant is seated and using their normal oxygen
prescription.
2. Patient will remain seated during the following procedure with SpO2 and heart rate
continuously being monitored.
Pulsed Oxygen Control at Rest:
1. Participant's oxygen will be turned off for 10 minutes as a washout period.
2. Using the oxygen tank with the pulse regulator, the participant will be titrated to a
pulse rate that maintains their SpO2 at an average of 95%.
a. Increasing volumes of oxygen in 1 L(liter)/min increments every thirty seconds until
an average of 95% SpO2 is maintained for 30 seconds.
3. Once the participant is titrated to the correct amount of oxygen, they will remain on
the oxygen for an additional 3 minutes
4. Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the
last minute of the test.
Mixed Continuous Air/Oxygen Efficacy at Rest:
5. Participant's oxygen will be turned off for 10 minutes as a washout period.
6. The participant will be delivered pulsed oxygen and high flow ambient air using the
oxygen tank with the pulse regulator and Vapotherm setup, the participant will be
titrated to a pulse rate that maintains their SpO2 at an average of 95%.
1. High flow ambient air will be set to 15 L/min
2. Increasing volumes of oxygen from in 1 L/min increments every thirty seconds until
an average of 95% SpO2 is maintained for 30 seconds.
7. Once the participant is titrated the correct amount of oxygen, they will remain on the
oxygen for an additional 3 minutes.
8. Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the
last minute of the test.
9. Steps 5-8 are then repeated two more times for pulsed oxygen plus continuous flow
ambient air at flow rates of 20 and 25 L/min.
Mixed Pulsed Air/Oxygen Efficacy at Rest:
10. Participant's oxygen will be turned off for 10 minutes as a washout period
11. The participant will be delivered the out-of-phase pulsed oxygen and high flow ambient
air using the oxygen tank with the pulse regulator and Vapotherm setup, the participant
will be titrated to a pulse rate that maintains their SpO2 at an average of 95%
1. High flow ambient air will be set to 15 L/min
2. Increasing volumes of oxygen from in 1L/min increments every thirty seconds until
an average of 95% SpO2 is maintained for 30 seconds.
12. Once the participant is titrated the correct amount of oxygen, they will remain on the
oxygen for an additional 3 minutes
13. Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the
last minute of the test.
14. Steps 10-13 are then repeated two more times for out-of phase pulsed oxygen plus pulsed
high flow ambient air at flow rates of 20 and 25 L/min.
