Pulmonary Disease, Chronic ObstructiveNCT04170062
Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest
A study testing Nasal Delivery of High-Flow Air and Oxygen Therapy and Nasal Delivery of Oxygen Therapy in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Pulmonary Fibrosis
- What is being tested?
- Nasal Delivery of High-Flow Air and Oxygen Therapy and Nasal Delivery of Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2020to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- 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
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- 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
Who cannot join
- Pregnancy or lactation
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 212187
Johns Hopkins Hospital Bayview Asthma and Allergy Center
Baltimore, Maryland, 21224
About this study
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:
- Pulses of pure oxygen (control)
- Constant high flow air with pulses of pure oxygen
- Out of phase pulses of high flow air and pure oxygen
Read the detailed description
Each participant will require (1) visit, which will last approximately 4-5 hours.
At start of visit:
- 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.
- Patient will remain seated during the following procedure with SpO2 and heart rate continuously being monitored.
Pulsed Oxygen Control at Rest:
- Participant's oxygen will be turned off for 10 minutes as a washout period.
- 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%.
- Increasing volumes of oxygen in 1 L(liter)/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds.
- Once the participant is titrated to the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes
- 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:
- Participant's oxygen will be turned off for 10 minutes as a washout period.
- 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%.
- High flow ambient air will be set to 15 L/min
- Increasing volumes of oxygen from in 1 L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds.
- Once the participant is titrated the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes.
- Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test.
- 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:
- Participant's oxygen will be turned off for 10 minutes as a washout period
- 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%
- High flow ambient air will be set to 15 L/min
- Increasing volumes of oxygen from in 1L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds.
- Once the participant is titrated the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes
- Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test.
- 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
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Pulmonary Fibrosis, Hypoxemia, Dyspnea, Oxygen Inhalation Therapy
- Being tested
- Nasal Delivery of High-Flow Air and Oxygen Therapy, Nasal Delivery of Oxygen Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Pulmonary Fibrosis, Hypoxia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Delivery of High-Flow Air and Oxygen TherapyDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline followed by intervention 1a | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 1b | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 1c | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 1d | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 1e | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 1f | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 2a | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 2b | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 2c | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 2d | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 2e | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
| Baseline followed by intervention 2f | Experimental | 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). Receives: Device: Nasal Delivery of High-Flow Air and Oxygen Therapy; Device: Nasal Delivery of Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
This will be assessed using the difference between the oxygen delivery systems (pure oxygen and mixed high-flow air with oxygen) in the L/min flow of oxygen required for a participant to reach steady state at greater than or equal to 95% pulse oxygenation.
Measured: up to 20 minutes
Secondary outcomes (1)
Dyspnea relief achieved with of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
This will be assessed using the difference in relative dyspnea score evaluated with the Borg Dyspnea scale at the end of each delivery method. The Borg scale ranges from 0-10. Min: 0 (No dyspnea), Max: 10 (Very,Very Severe dyspnea).
Measured: Approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start15 Dec 2020
- Primary completion31 Dec 2023
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Chest Physicians
- Responsible party
- Sponsor
- Investigators
- Sonye Danoff, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170062
- Sponsor's protocol ID
- IRB00206318
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2019
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Savings With Administered Oxygen and High Flow Ambient Air At Rest
- ClinicalTrials.gov ID
- NCT04170062
- Acronym / sponsor ID
- IRB00206318
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Pulmonary Fibrosis, Hypoxemia, Dyspnea, Oxygen Inhalation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American College of Chest Physicians
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pulses of pure oxygen (control)
- Constant high flow air with pulses of pure oxygen
- Out of phase pulses of high flow air and pure oxygen
Detailed description
Each participant will require (1) visit, which will last approximately 4-5 hours.
At start of visit:
- 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.
- Patient will remain seated during the following procedure with SpO2 and heart rate continuously being monitored.
Pulsed Oxygen Control at Rest:
- Participant's oxygen will be turned off for 10 minutes as a washout period.
- 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%.
- Increasing volumes of oxygen in 1 L(liter)/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds.
- Once the participant is titrated to the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes
- 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:
- Participant's oxygen will be turned off for 10 minutes as a washout period.
- 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%.
- High flow ambient air will be set to 15 L/min
- Increasing volumes of oxygen from in 1 L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds.
- Once the participant is titrated the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes.
- Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test.
- 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:
- Participant's oxygen will be turned off for 10 minutes as a washout period
- 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%
- High flow ambient air will be set to 15 L/min
- Increasing volumes of oxygen from in 1L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds.
- Once the participant is titrated the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes
- Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Baseline followed by intervention 1a | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 1b | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 1c | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 1d | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 1e | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 1f | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 2a | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 2b | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 2c | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 2d | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 2e | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
| Baseline followed by intervention 2f | Experimental | Device: Nasal Delivery of High-Flow Air and Oxygen Therapy, Device: Nasal Delivery of Oxygen TherapySubjects 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). |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- 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
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Delivery of High-Flow Air and Oxygen TherapyThey 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. | Device | Baseline followed by intervention 1a, Baseline followed by intervention 1b, Baseline followed by intervention 1c, Baseline followed by intervention 1d, Baseline followed by intervention 1e, Baseline followed by intervention 1f, Baseline followed by intervention 2a, Baseline followed by intervention 2b, Baseline followed by intervention 2c, Baseline followed by intervention 2d, Baseline followed by intervention 2e, Baseline followed by intervention 2f |
| Nasal Delivery of Oxygen TherapyThey 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. | Device | Baseline followed by intervention 1a, Baseline followed by intervention 1b, Baseline followed by intervention 1c, Baseline followed by intervention 1d, Baseline followed by intervention 1e, Baseline followed by intervention 1f, Baseline followed by intervention 2a, Baseline followed by intervention 2b, Baseline followed by intervention 2c, Baseline followed by intervention 2d, Baseline followed by intervention 2e, Baseline followed by intervention 2f |
Primary outcome
Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
Time frame: up to 20 minutes
This will be assessed using the difference between the oxygen delivery systems (pure oxygen and mixed high-flow air with oxygen) in the L/min flow of oxygen required for a participant to reach steady state at greater than or equal to 95% pulse oxygenation.
1 secondary outcome
Dyspnea relief achieved with of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy
Time frame: Approximately 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonye Danoff, MD, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Delivery of High-Flow Air and Oxygen Therapy and Nasal Delivery of Oxygen Therapy in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of partial replacement of concentrated oxygen by high flow ambient air for Long Term Oxygen Therapy (time frame: up to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.