Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest
NCT ID: NCT04170062
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2020-12-15
2024-12-16
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Baseline followed by intervention 1a
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 1b
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 1c
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 1d
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 1e
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 1f
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 2a
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 20 L/min, 25 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 2b
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 15 L/min, 25 L/min, 20 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 2c
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 15 L/min, 25 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 2d
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 20 L/min, 25 L/min, 15 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 2e
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 15 L/min, 20 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Baseline followed by intervention 2f
Subjects perform baseline titration with oxygen only first. Subjects are then titrated with six different delivery methods. The subjects will be first delivered Out-of-Phase pulsed high-flow air and oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min) and then Continuous high-flow air with pulsed oxygen (order of high-flow air flow rate: 25 L/min, 20 L/min, 15 L/min).
Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Interventions
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Nasal Delivery of High-Flow Air and Oxygen Therapy
They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Nasal Delivery of Oxygen Therapy
They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
Eligibility Criteria
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Inclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged greater or equal to 30 years old
* Require Long Term Oxygen Therapy between 1 L/min and 4 L/min while at rest
* Have a peripheral blood saturation level above 80% with room air while seated
* Tolerate breathing while seated in room air
* Diagnosed with one of the following respiratory diseases: COPD (40% \< Forced Expiratory Volume (FEV1) \< 80% confirmed from pulmonary function test (PFT) within the last year), ILD (Confirmed with radiographic imaging), PH (Confirmed with radiographic imaging)
* Normal heart rate and blood pressure (Resting Heart Rate \<120 bpm, Systolic BP \<180 mmHg, Diastolic BP \<100mmHg)
* PFT taken in the last three months
Exclusion Criteria
* Exacerbation that has resolved within the past 28 days
* Treatment with another investigational drug or other intervention within three months
* Has any of the following: unstable angina, recent revascularization, recent history of cerebrovascular accident
30 Years
100 Years
ALL
No
Sponsors
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American College of Chest Physicians
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Sonye Danoff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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The Johns Hopkins Hospital
Baltimore, Maryland, United States
Johns Hopkins Hospital Bayview Asthma and Allergy Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00206318
Identifier Type: -
Identifier Source: org_study_id