Pulmonary Disease, Chronic ObstructiveNCT03221387
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
A study testing Humidified nasal high flow with oxygen in people with Pulmonary Disease, Chronic Obstructive and Hypercapnia, run by Temple University at 1 site in United States.
Trial summary
Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized. The usefulness of this therapy in the outpatient setting is unproven. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxia
- What is being tested?
- Humidified nasal high flow with oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2017to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks
- have COPD as the primary diagnosis
- have smoked > 10 pack years.
- receiving supplemental oxygen as part of their usual clinical care.
- willing to give informed consent
Who cannot join
- upper airway or nasal problems that prohibit the use of high flow oxygen
- current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV)
- sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI > 35 kg/m2; or Berlin questionnaire scores suggesting high likelihood of sleep apnea with increased risk of sleep-related accident (e.g., occupation as a commercial driver or pilot);
- excessive daytime sleepiness (i.e., either of High (>15) score on the Epworth Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (< 12 Wks.) Hospitalization for AECOPD for 90 Days
Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized. The usefulness of this therapy in the outpatient setting is unproven. This pilot study will test the feasibility of using this therapy in the outpatient setting and its effects on sleep.
Read the detailed description
Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure. HNHF-O2 may be beneficial in patients with COPD and chronic impairments in gas exchange, both hypoxemia as well as hypercapnia. HNHF-O2 may decrease work of breathing, reduce dyspnea, improve airway humidification, and potentially stabilize or reduce carbon dioxide levels. However, there is limited data showing the chronic effects of HNHF-O2 in patients with hypercapnic respiratory failure, specifically those discharged to home following hospitalization for an acute exacerbation. Data that demonstrates that HNHF-O2 is well tolerated, and stabilizes or improves gas exchange long term in patients with COPD is lacking. Similarly, data that demonstrates that this therapeutic regimen is feasible to provide to patients in the home environment are lacking. This is an open-labeled pilot study of thirty patients to determine the safety and feasibility of using the device in the outpatient management of patients with COPD. A subset of ten patients will have serial sleep studies to determine the effects, if any, on sleep.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxia
- Being tested
- Humidified nasal high flow with oxygen
- Keywords
- Therapy, Noninvasive Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidified nasal high flow with oxygenDevice
Also called AIRVO 2
The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.
| Study group | Role | What they receive |
|---|---|---|
| Nasal high flow with oxygen | Other | While in the clinic High Flow Nasal Cannula oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting. Receives: Device: Humidified nasal high flow with oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Oxygen Therapy by HNHF-O2 at Home
Number of hours of use of the device per day as recorded on the device
Measured: 90 days
Secondary outcomes (3)
Spirometry
Change in FEV1
Measured: 90 days
Change in 6 Minute Walk Distance
Total distance walked in 6 minutes
Measured: 90 days
Breathlessness
Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start10 Sep 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Gerard J Criner, MD, Principal investigator, Temple University Lewis Katz School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221387
- Sponsor's protocol ID
- 24406
- Status last verified
- May 2021
- First submitted
- 13 Jul 2017
- Last updated
- 7 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (< 12 Wks.) Hospitalization for AECOPD for 90 Days
- ClinicalTrials.gov ID
- NCT03221387
- Acronym / sponsor ID
- 24406
- Conditions
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoxia
- Keywords
- Therapy, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized. The usefulness of this therapy in the outpatient setting is unproven. This pilot study will test the feasibility of using this therapy in the outpatient setting and its effects on sleep.
Detailed description
Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute beneficial effects in patients with hypoxemic respiratory failure. HNHF-O2 may be beneficial in patients with COPD and chronic impairments in gas exchange, both hypoxemia as well as hypercapnia. HNHF-O2 may decrease work of breathing, reduce dyspnea, improve airway humidification, and potentially stabilize or reduce carbon dioxide levels. However, there is limited data showing the chronic effects of HNHF-O2 in patients with hypercapnic respiratory failure, specifically those discharged to home following hospitalization for an acute exacerbation. Data that demonstrates that HNHF-O2 is well tolerated, and stabilizes or improves gas exchange long term in patients with COPD is lacking. Similarly, data that demonstrates that this therapeutic regimen is feasible to provide to patients in the home environment are lacking. This is an open-labeled pilot study of thirty patients to determine the safety and feasibility of using the device in the outpatient management of patients with COPD. A subset of ten patients will have serial sleep studies to determine the effects, if any, on sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow with oxygen | Other | Device: Humidified nasal high flow with oxygenWhile in the clinic High Flow Nasal Cannula oxygen will be passed through a heated humidifier (AIRVO-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs (Optiflow+ Fisher and Paykel Healthcare), with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep arterial oxygen saturation (SaO2) > 90%. Temperature will be adjusted based on patient's comfort and range from 34-37 degrees based on prior experience. The subject will be discharged to home and instructed to use the high flow nasal cannula system at night and during the daytime while at home and resting. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks
- have COPD as the primary diagnosis
- have smoked > 10 pack years.
- receiving supplemental oxygen as part of their usual clinical care.
- willing to give informed consent
Key exclusion criteria (4 listed)
- upper airway or nasal problems that prohibit the use of high flow oxygen
- current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV)
- sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI > 35 kg/m2; or Berlin questionnaire scores suggesting high likelihood of sleep apnea with increased risk of sleep-related accident (e.g., occupation as a commercial driver or pilot);
- excessive daytime sleepiness (i.e., either of High (>15) score on the Epworth Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12 months).
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 |
|---|---|---|
| Humidified nasal high flow with oxygenAlso: AIRVO 2The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. | Device | Nasal high flow with oxygen |
Primary outcome
Use of Oxygen Therapy by HNHF-O2 at Home
Time frame: 90 days
Number of hours of use of the device per day as recorded on the device
3 secondary outcomes
Spirometry
Time frame: 90 days
Change in 6 Minute Walk Distance
Time frame: 90 days
Breathlessness
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gerard J Criner, MD principal investigator
Temple University Lewis Katz School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidified nasal high flow with oxygen in people with Pulmonary Disease, Chronic Obstructive and Hypercapnia, run by Temple University at 1 site 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 5 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Use of Oxygen Therapy by HNHF-O2 at Home (time frame: 90 days). 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 7 Jun 2021.