COPD Exacerbation AcuteNCT05182294
Tolerance and Acute Effects of a New HFNT Nasal Cannula
A study testing AIRVO 2, the new asymmetric nasal cannula in people with COPD Exacerbation Acute, run by Temple University at 1 site in United States.
Trial summary
In the care of patients experiencing an acute exacerbation of COPD, supplemental oxygen therapy is often required. Oxygen is typically administered at flow rates between 1 and 4 liters per minute. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- What is being tested?
- AIRVO 2, the new asymmetric nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 31 Jan 2023
- 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
- i.aged ≥ 40 years (ii) hospitalization for acute exacerbation of COPD; (iii) smoker or ex-smoker (iv) FEV1 <80% of predicted and FEV1/FVC <70% postbronchodilator within 12 months prior to admission (v) have no other lung disease (including asthma) as a principal cause of pulmonary function limitation (vi) baseline PaCO2 ≥ 45 mm Hg at study entry. (vii) willing to give informed consent (viii) willing to participate in measurement of ABGs (ix) will to provide a brief history and physical examination and answer questionnaires.
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Women who are known to be pregnant at the time of hospital admission
- Prisoners
- Individuals who do not understand English
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 a New HFNT Nasal Cannula on Comfort, Vital Signs, Breathing Pattern and Gas Exchange in Patients Hospitalized With an Acute Exacerbation of COPD
In the care of patients experiencing an acute exacerbation of COPD, supplemental oxygen therapy is often required. Oxygen is typically administered at flow rates between 1 and 4 liters per minute. High-flow nasal therapy (HFNT) has been reported to have beneficial effects in patients with hypoxemic respiratory failure and in hospitalized and non-hospitalized patients with severe COPD. Clinical efficacy in improving gas exchange depends upon patient tolerance and device-related properties such as flow rate and creation of turbulent flow in the conducting airways to improve oxygenation and carbon dioxide elimination. Alterations of nasal prong structure, such as nasal prong dimensions, may produce more robust turbulent flow at lower flow rates thereby improving gas exchange as well as patient tolerance. In this pilot study we will assess the impact of a new nasal cannula with asymmetric cannula dimensions that may create more turbulent flow at lower flow rates compared to the current symmetric nasal cannula on patient comfort as well as vital signs, pulse oximetry, breathing pattern and parameters of gas exchange in hospitalized patients with a COPD exacerbation.
Read the detailed description
AIRVO 2: The AIRVO 2 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patient through a variety of patient interfaces. This is an FDA-approved 510k device for use in hospitals and nursing homes. During HFNT, oxygen will be passed through a heated humidifier (AIRVO 2, Fisher and Paykel Healthcare) and applied continuously through conventional large-bore binasal symmetric prongs or the new asymmetric prongs cannula device, with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep SaO2 ≥ 90% (Airvo 2, Fisher and Paykel Healthcare). Gas flow temperature will be adjusted based on patient's comfort and range from 34-37 degrees centigrade. After completion of the study, patients will be switched back to oxygen therapy administered by nasal prongs or mask.
This is a pilot study in which the primary outcome is to determine the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas. It is not an efficacy trial and there is no formal power analysis. All subjects are randomly assigned to two sequences, and each subject is treated subsequently with two treatments, the order of the treatments depends on its sequence. Initially, the primary endpoint and secondary endpoints will be evaluated for a carryover effect, a period effect, and a treatment effect with the use of two-tailed t-tests. We will then model treatment effects, period effects, and carryover effects using the linear mixed-effects model for this 2x2 crossover study.
Subjects may discontinue participation in the study at any point and for any reason. This decision will not be held against them in any way. If a subject decides to withdraw, the physician will assess their clinical condition and determine the best course of action for the subject. This may include alternative methods of oxygen administration. Any data that is collected up to the point of subject withdrawal will be retained for analysis.
Risks to Subjects
The AIRVO 2 is an FDA cleared device (510k number K131895). There are few expected side effects of using the AIRVO 2 device - if the humidification is too low, the subject may experience nasal/throat discomfort or epistaxis. It has been determined to be a non-significant risk device in that it meets none of the criteria for a significant risk device.
Potential Benefits to Subjects
Potential benefits of study participation include the subject experiencing a decreased work of breathing with high flow nasal therapy provided by one or both of the nasal cannulas. It is also possible that the subject will experience no direct benefit.
Privacy and Confidentiality
All data will be stored on the REDCap website. The site is 21 CFR part 11 compliant. All study personnel have been trained in human subjects protections and good clinical practices. Study data will only be accessible to study personnel via password protected websites and computer terminals.
A "HIPAA Authorization English (HRP-505)" has been provided with this submission.
Economic Burden to Subjects
All subjects will need supplemental oxygen as part of their clinical care. The only difference for this research is that the subjects will receive high-flow oxygen through two different nasal cannulas. There is no additional charge for this method of oxygen delivery.
- Conditions
- COPD Exacerbation Acute
- Being tested
- AIRVO 2, the new asymmetric nasal cannula
- Keywords
- Hypercapnia (PaCO2 ≥ 45 mm Hg)
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRVO 2, the new asymmetric nasal cannulaDevice
Also called Conventional asymmetric nasal cannula
The AIRVO 2 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patient through a variety of patient interfaces. This is an FDA-approved 510k device for use in hospitals and nursing homes. During HFNT, oxygen will be passed through a heated humidifier (AIRVO 2, Fisher and Paykel Healthcare) and applied continuously through conventional large-bore binasal symmetric prongs or the new asymmetric prongs cannula device, with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep SaO2 ≥ 90% (Airvo 2, Fisher and Paykel Healthcare). Gas flow temperature will be adjusted based on patient's comfort and range from 34-37 degrees centigrade. After completion of the study, patients will be switched back to oxygen therapy administered by nasal prongs or mask..
| Study group | Role | What they receive |
|---|---|---|
| Conventional symmetric nasal cannula | Active comparator | The patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered Receives: Device: AIRVO 2, the new asymmetric nasal cannula |
| AIRVO 2; new asymmetric nasal cannula | Active comparator | The patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered Receives: Device: AIRVO 2, the new asymmetric nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas.
This is a pilot study in which the primary outcome is to determine the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas. The level of comfort will be assessed by a 100 mm visual analog scale from 0 (no discomfort) to 100 (maximal imaginable discomfort)
Measured: 6 hours
Sensation of shortness of breath
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 and overall comfort
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start25 May 2022
- Primary completion14 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula and receive HFNT for 2 hours during the first session. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session.Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered. At the end of this second session the patient will be discharged from the study and receive usual medical care for the COPD exacerbation and other medical conditions as clinically indicated.
- Masking
- None (open label)
- Enrolment
- 14 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182294
- Sponsor's protocol ID
- 1319877
- Status last verified
- Apr 2023
- First submitted
- 14 Dec 2021
- Last updated
- 6 Apr 2023
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acute Effects of a New HFNT Nasal Cannula on Comfort, Vital Signs, Breathing Pattern and Gas Exchange in Patients Hospitalized With an Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT05182294
- Acronym / sponsor ID
- 1319877
- Conditions
- COPD Exacerbation Acute
- Keywords
- Hypercapnia (PaCO2 ≥ 45 mm Hg)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 25 May 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 10 Jan 2022 (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.
In the care of patients experiencing an acute exacerbation of COPD, supplemental oxygen therapy is often required. Oxygen is typically administered at flow rates between 1 and 4 liters per minute. High-flow nasal therapy (HFNT) has been reported to have beneficial effects in patients with hypoxemic respiratory failure and in hospitalized and non-hospitalized patients with severe COPD. Clinical efficacy in improving gas exchange depends upon patient tolerance and device-related properties such as flow rate and creation of turbulent flow in the conducting airways to improve oxygenation and carbon dioxide elimination. Alterations of nasal prong structure, such as nasal prong dimensions, may produce more robust turbulent flow at lower flow rates thereby improving gas exchange as well as patient tolerance. In this pilot study we will assess the impact of a new nasal cannula with asymmetric cannula dimensions that may create more turbulent flow at lower flow rates compared to the current symmetric nasal cannula on patient comfort as well as vital signs, pulse oximetry, breathing pattern and parameters of gas exchange in hospitalized patients with a COPD exacerbation.
Detailed description
AIRVO 2: The AIRVO 2 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patient through a variety of patient interfaces. This is an FDA-approved 510k device for use in hospitals and nursing homes. During HFNT, oxygen will be passed through a heated humidifier (AIRVO 2, Fisher and Paykel Healthcare) and applied continuously through conventional large-bore binasal symmetric prongs or the new asymmetric prongs cannula device, with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep SaO2 ≥ 90% (Airvo 2, Fisher and Paykel Healthcare). Gas flow temperature will be adjusted based on patient's comfort and range from 34-37 degrees centigrade. After completion of the study, patients will be switched back to oxygen therapy administered by nasal prongs or mask.
This is a pilot study in which the primary outcome is to determine the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas. It is not an efficacy trial and there is no formal power analysis. All subjects are randomly assigned to two sequences, and each subject is treated subsequently with two treatments, the order of the treatments depends on its sequence. Initially, the primary endpoint and secondary endpoints will be evaluated for a carryover effect, a period effect, and a treatment effect with the use of two-tailed t-tests. We will then model treatment effects, period effects, and carryover effects using the linear mixed-effects model for this 2x2 crossover study.
Subjects may discontinue participation in the study at any point and for any reason. This decision will not be held against them in any way. If a subject decides to withdraw, the physician will assess their clinical condition and determine the best course of action for the subject. This may include alternative methods of oxygen administration. Any data that is collected up to the point of subject withdrawal will be retained for analysis.
Risks to Subjects
The AIRVO 2 is an FDA cleared device (510k number K131895). There are few expected side effects of using the AIRVO 2 device - if the humidification is too low, the subject may experience nasal/throat discomfort or epistaxis. It has been determined to be a non-significant risk device in that it meets none of the criteria for a significant risk device.
Potential Benefits to Subjects
Potential benefits of study participation include the subject experiencing a decreased work of breathing with high flow nasal therapy provided by one or both of the nasal cannulas. It is also possible that the subject will experience no direct benefit.
Privacy and Confidentiality
All data will be stored on the REDCap website. The site is 21 CFR part 11 compliant. All study personnel have been trained in human subjects protections and good clinical practices. Study data will only be accessible to study personnel via password protected websites and computer terminals.
A "HIPAA Authorization English (HRP-505)" has been provided with this submission.
Economic Burden to Subjects
All subjects will need supplemental oxygen as part of their clinical care. The only difference for this research is that the subjects will receive high-flow oxygen through two different nasal cannulas. There is no additional charge for this method of oxygen delivery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula and receive HFNT for 2 hours during the first session. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session.Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered. At the end of this second session the patient will be discharged from the study and receive usual medical care for the COPD exacerbation and other medical conditions as clinically indicated.
| Arm | Type | Receives |
|---|---|---|
| Conventional symmetric nasal cannula | Active comparator | Device: AIRVO 2, the new asymmetric nasal cannulaThe patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered |
| AIRVO 2; new asymmetric nasal cannula | Active comparator | Device: AIRVO 2, the new asymmetric nasal cannulaThe patient's breathing pattern will be assessed by inductive plethysmography while using the cannula and receive HFNT for 2 hours during the first session. Patients will then be randomized to use of the conventional symmetric nasal cannula or the new asymmetric nasal cannula. At the end of the first session questionnaire data will be collected and ABGs will be repeated followed by a 30-minute rest period without any device. Patients will then crossover to receive HFNT via the other cannula type for another 2 hours during the second session. Inductive plethysmography will again be worn and ABGs will be obtained, and questionnaires will again be administered |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- i.aged ≥ 40 years (ii) hospitalization for acute exacerbation of COPD; (iii) smoker or ex-smoker (iv) FEV1 <80% of predicted and FEV1/FVC <70% postbronchodilator within 12 months prior to admission (v) have no other lung disease (including asthma) as a principal cause of pulmonary function limitation (vi) baseline PaCO2 ≥ 45 mm Hg at study entry. (vii) willing to give informed consent (viii) willing to participate in measurement of ABGs (ix) will to provide a brief history and physical examination and answer questionnaires.
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Women who are known to be pregnant at the time of hospital admission
- Prisoners
- Individuals who do not understand English
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 |
|---|---|---|
| AIRVO 2, the new asymmetric nasal cannulaAlso: Conventional asymmetric nasal cannulaThe AIRVO 2 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patient through a variety of patient interfaces. This is an FDA-approved 510k device for use in hospitals and nursing homes. During HFNT, oxygen will be passed through a heated humidifier (AIRVO 2, Fisher and Paykel Healthcare) and applied continuously through conventional large-bore binasal symmetric prongs or the new asymmetric prongs cannula device, with a gas flow rate of 20-35 liters per minute or as high as the patient will tolerate and an FiO2 to keep SaO2 ≥ 90% (Airvo 2, Fisher and Paykel Healthcare). Gas flow temperature will be adjusted based on patient's comfort and range from 34-37 degrees centigrade. After completion of the study, patients will be switched back to oxygen therapy administered by nasal prongs or mask.. | Device | AIRVO 2; new asymmetric nasal cannula, Conventional symmetric nasal cannula |
Primary outcome
Determining the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas.
Time frame: 6 hours
This is a pilot study in which the primary outcome is to determine the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas. The level of comfort will be assessed by a 100 mm visual analog scale from 0 (no discomfort) to 100 (maximal imaginable discomfort)
Sensation of shortness of breath
Time frame: 6 hours
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 and overall comfort
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 6 Apr 2023.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRVO 2, the new asymmetric nasal cannula in people with COPD Exacerbation Acute, 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 1 inclusion and 5 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 6 Apr 2023. 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?
Determining the level of comfort experienced by the patient of using high-flow nasal oxygen administered by two different nasal cannulas. (time frame: 6 hours). The study lists 2 primary outcomes in all. 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 6 Apr 2023.