Chronic Obstructive Pulmonary DiseaseNCT03214458
Effects of Nasal High-flow Oxygen in Patients With an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
A study testing Nasal high flow in people with Chronic Obstructive Pulmonary Disease, run by Temple University at 1 site in United States.
Trial summary
The investigators are looking at the effect of humidified nasal high-flow with oxygen (HNHF-O2) on air exchange during exacerbations of COPD. HNHF-O2 therapy may have beneficial effects in patients with severe breathing impairment that results in low oxygen in the blood. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Nasal high flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 18 Apr 2018
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 40 years of age or older
- Hospitalized for an acute exacerbation of COPD on the 6th floor of Rock Pavilion (pulmonary inpatient service)
- Smoking history of > 10 pack-years
- PaCO2 ≥ 45 mm Hg
- Able to provide informed consent
- Willing to participate in daily measurements of arterial blood gases, completion of study questionnaires, and other study-related procedures
Who cannot join
- Upper airway or nasal problems that prohibit the use of humidified high-flow nasal oxygen
- Hemodynamic instability defined as the need for blood pressure or blood volume support to maintain adequate tissue perfusion and oxygenation
- Urgent need for endotracheal intubation
- A do-not-intubate order
- A known diagnosis of obstructive sleep apnea
- Present use of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Tolerance and Acute Effects of Humidified Nasal High-flow With Oxygen (HNHF-O2) on Gas Exchange in Patients Hospitalized With an Acute Exacerbation of COPD
The investigators are looking at the effect of humidified nasal high-flow with oxygen (HNHF-O2) on air exchange during exacerbations of COPD. HNHF-O2 therapy may have beneficial effects in patients with severe breathing impairment that results in low oxygen in the blood. Some studies show that patients with low blood oxygen levels who use HFNC oxygen have lower rates of needing mechanical ventilation.
Read the detailed description
Patients admitted to the hospital with an exacerbation of COPD accompanied by respiratory failure need supplemental oxygen and alleviation of an increased work of breathing. Patients with acute exacerbations of COPD have hypoxemia, hypercapnia and an elevated work of breathing due to increased airways obstruction and hyperinflation. Patient outcomes can be improved by aggressive bronchodilation and systemic corticosteroids, but methods that can augment spontaneous ventilation and decrease the work of breathing can help avoid intubation. High flow nasal cannula (HFNC) has been shown to be useful in patients with severe hypoxemic respiratory failure and those recently extubated from mechanical ventilation. HFNC provides warmed and humidified high flow (10-60L/min) by nasal cannula that allows precise titration of % inspired FiO2 in the air/oxygen blend. The AIRVO 2 device delivers warmed and humidified respiratory gases to spontaneously breathing patients using a humidifier and integrated flow generator. In this study, the air/ oxygen gas blend (20-35L/min) will be administered by the AIRVO 2 HNHF device to achieve an fraction of inspired oxygen (FiO2) > 90% at rest. A potential advantage of the AIRVO 2 HNHF device includes the ability of the device to deliver oxygen that has been warmed and humidified. Also, the high flow rates achieved with this device may reduce the work of breathing. This is an open-labeled pilot study of ten patients to determine the safety and feasibility of using the device in the management of patients with an acute exacerbation of COPD with acute on chronic respiratory failure.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Nasal high flow
- Keywords
- Therapy, Noninvasive Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flowDevice
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 | During HFNC-oxygen, 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. Receives: Device: Nasal high flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to maintain oxygen saturation at or above 90%
The need to intensify therapy because HNHF-O2 does not achieve the targeted oxygen saturation of ≥ 90% resulting in the need to intensify respiratory support
Measured: 3 days
Secondary outcomes (2)
Tolerance of HNHF-O2 measured by a 5-point Likert Scale
Likert scale model indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2) in patient's sensation of shortness of breath.
Measured: 3 days
Tolerance of HNHF-O2 measured by a 100 mm visual analog scale
Discomfort assessed using an unmarked 100 mm visual analogic scale from "no discomfort" to "maximal imaginable discomfort"
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start20 Jul 2017
- Primary completion16 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214458
- Sponsor's protocol ID
- 24408
- Status last verified
- Apr 2018
- First submitted
- 19 Jun 2017
- Last updated
- 19 Apr 2018
- Results posted
- No
- 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 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acute Effects of Humidified Nasal High-flow With Oxygen (HNHF-O2) on Gas Exchange in Patients Hospitalized With an Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT03214458
- Acronym / sponsor ID
- 24408
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Therapy, Noninvasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 11 Jul 2017 (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.
The investigators are looking at the effect of humidified nasal high-flow with oxygen (HNHF-O2) on air exchange during exacerbations of COPD. HNHF-O2 therapy may have beneficial effects in patients with severe breathing impairment that results in low oxygen in the blood. Some studies show that patients with low blood oxygen levels who use HFNC oxygen have lower rates of needing mechanical ventilation.
Detailed description
Patients admitted to the hospital with an exacerbation of COPD accompanied by respiratory failure need supplemental oxygen and alleviation of an increased work of breathing. Patients with acute exacerbations of COPD have hypoxemia, hypercapnia and an elevated work of breathing due to increased airways obstruction and hyperinflation. Patient outcomes can be improved by aggressive bronchodilation and systemic corticosteroids, but methods that can augment spontaneous ventilation and decrease the work of breathing can help avoid intubation. High flow nasal cannula (HFNC) has been shown to be useful in patients with severe hypoxemic respiratory failure and those recently extubated from mechanical ventilation. HFNC provides warmed and humidified high flow (10-60L/min) by nasal cannula that allows precise titration of % inspired FiO2 in the air/oxygen blend. The AIRVO 2 device delivers warmed and humidified respiratory gases to spontaneously breathing patients using a humidifier and integrated flow generator. In this study, the air/ oxygen gas blend (20-35L/min) will be administered by the AIRVO 2 HNHF device to achieve an fraction of inspired oxygen (FiO2) > 90% at rest. A potential advantage of the AIRVO 2 HNHF device includes the ability of the device to deliver oxygen that has been warmed and humidified. Also, the high flow rates achieved with this device may reduce the work of breathing. This is an open-labeled pilot study of ten patients to determine the safety and feasibility of using the device in the management of patients with an acute exacerbation of COPD with acute on chronic respiratory failure.
Study design
- Primary purpose
- Device feasibility
- 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: Nasal high flowDuring HFNC-oxygen, 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females 40 years of age or older
- Hospitalized for an acute exacerbation of COPD on the 6th floor of Rock Pavilion (pulmonary inpatient service)
- Smoking history of > 10 pack-years
- PaCO2 ≥ 45 mm Hg
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Upper airway or nasal problems that prohibit the use of humidified high-flow nasal oxygen
- Hemodynamic instability defined as the need for blood pressure or blood volume support to maintain adequate tissue perfusion and oxygenation
- Urgent need for endotracheal intubation
- A do-not-intubate order
- A known diagnosis of obstructive sleep apnea
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 high flowThe 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
Ability to maintain oxygen saturation at or above 90%
Time frame: 3 days
The need to intensify therapy because HNHF-O2 does not achieve the targeted oxygen saturation of ≥ 90% resulting in the need to intensify respiratory support
2 secondary outcomes
Tolerance of HNHF-O2 measured by a 5-point Likert Scale
Time frame: 3 days
Tolerance of HNHF-O2 measured by a 100 mm visual analog scale
Time frame: 3 days
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 19 Apr 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high flow in people with Chronic Obstructive Pulmonary Disease, 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 6 inclusion and 6 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 19 Apr 2018. 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?
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?
Ability to maintain oxygen saturation at or above 90% (time frame: 3 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 19 Apr 2018.