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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humidified nasal high flow with oxygen | Device | The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Oxygen Therapy by HNHF-O2 at Home | Number of hours of use of the device per day as recorded on the device | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry | Change in FEV1 | 90 days |
| Change in 6 Minute Walk Distance | Total distance walked in 6 minutes | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Quantity | Volume of sputum | Measured daily for 90 days |
| Sputum Consistency | Watery, thin, thick, none, no report made | Measured daily for 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard J Criner, MD | Temple University Lewis Katz School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal High Flow With Oxygen | 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. Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal High Flow With Oxygen | 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. Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self-reported age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Use of Oxygen Therapy by HNHF-O2 at Home | Number of hours of use of the device per day as recorded on the device | Posted | Mean | Standard Deviation | Hours | 90 days |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal High Flow With Oxygen | 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. Humidified nasal high flow with oxygen: The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. |
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Single center study; no active control group; feasibility study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Nester, JD, MS | Lewis Katz School of Medicine at Temple University | 215-707-1986 | coisom@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2017 | Apr 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006935 | Hypercapnia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| Breathlessness | Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath | 90 days |
| Sputum Color | Clear, yellow, brown, white, none | Measured daily for 90 days |
| Peak Flow | liters/minute | Measured daily for 90 days |
| Body Temperature > 100 Degrees F | Yes/no Subjects recorded body temperature via thermometer | Measured daily for 90 days |
| Presence of Cough | Yes/no | Measured daily for 90 days |
| Presence of Wheeze | Yes/no | Measured daily for 90 days |
| Presence of Sore Throat | Yes/no | Measured daily for 90 days |
| Presence of Nasal Congestion | Yes/no | Measured daily for 90 days |
| Polysomnography | Heart rate | 70 days |
| Polysomnography | Pulse oximetry | 70 days |
| Polysomnography | Total sleep time in hours | 70 days |
| Polysomnography | Sleep efficiency (percent of time sleeping/total amount of time in bed) | 70 days |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| GOLD grade at enrollment | GOLD grade is based on FEV1 GOLD 2 Moderate airflow limitation 50% <=FEV1 <80% predicted GOLD 3 Severe airflow limitation 30% <= FEV1 < 50 % predicted GOLD 4 Very severe airflow limitation FEV1 < 30% predicted | Number | participants |
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| Secondary | Spirometry | Change in FEV1 | Posted | Mean | Standard Deviation | Liters | 90 days |
|
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| Secondary | Change in 6 Minute Walk Distance | Total distance walked in 6 minutes | Posted | Mean | Standard Error | meters | 90 days |
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| Secondary | Breathlessness | Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath | Posted | Mean | Standard Error | score on a scale | 90 days |
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| Other Pre-specified | Sputum Quantity | Volume of sputum | Posted | Count of Participants | Participants | Measured daily for 90 days |
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| Other Pre-specified | Sputum Consistency | Watery, thin, thick, none, no report made | Posted | Number | Daily reports made | Measured daily for 90 days |
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| Other Pre-specified | Sputum Color | Clear, yellow, brown, white, none | Posted | Count of Participants | Participants | Measured daily for 90 days |
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| Other Pre-specified | Peak Flow | liters/minute | Posted | Mean | 95% Confidence Interval | Liters/minute | Measured daily for 90 days |
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| Other Pre-specified | Body Temperature > 100 Degrees F | Yes/no Subjects recorded body temperature via thermometer | Posted | Number | percentage of days with fever reported | Measured daily for 90 days |
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| Other Pre-specified | Presence of Cough | Yes/no | Posted | Count of Participants | Participants | Measured daily for 90 days |
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| Other Pre-specified | Presence of Wheeze | Yes/no | Posted | Count of Participants | Participants | Measured daily for 90 days |
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| Other Pre-specified | Presence of Sore Throat | Yes/no | Posted | Count of Participants | Participants | Measured daily for 90 days |
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| Other Pre-specified | Presence of Nasal Congestion | Yes/no | Posted | Count of Participants | Participants | Measured daily for 90 days |
|
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| Other Pre-specified | Polysomnography | Heart rate | Not Posted | 70 days | Participants |
| Other Pre-specified | Polysomnography | Pulse oximetry | Not Posted | 70 days | Participants |
| Other Pre-specified | Polysomnography | Total sleep time in hours | Not Posted | 70 days | Participants |
| Other Pre-specified | Polysomnography | Sleep efficiency (percent of time sleeping/total amount of time in bed) | Not Posted | 70 days | Participants |
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| Title | Measurements |
|---|
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| Watery |
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| No report made |
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| Brown |
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| Green |
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