Hypercapnia, Hypoxia, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Therapy, Noninvasive Ventilation
Brief 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. 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.
Interventions
DEVICEHumidified 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.
Sponsors
Fisher and Paykel Healthcare
Temple University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Oxygen Therapy by HNHF-O2 at Home | 90 days | Number of hours of use of the device per day as recorded on the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Walk Distance | 90 days | Total distance walked in 6 minutes |
| Breathlessness | 90 days | Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath |
| Spirometry | 90 days | Change in FEV1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sputum Quantity | Measured daily for 90 days | Volume of sputum |
| Body Temperature > 100 Degrees F | Measured daily for 90 days | Yes/no Subjects recorded body temperature via thermometer |
| Presence of Cough | Measured daily for 90 days | Yes/no |
| Presence of Wheeze | Measured daily for 90 days | Yes/no |
| Presence of Sore Throat | Measured daily for 90 days | Yes/no |
| Presence of Nasal Congestion | Measured daily for 90 days | Yes/no |
| Polysomnography | 70 days | Heart rate |
| Sputum Consistency | Measured daily for 90 days | Watery, thin, thick, none, no report made |
| Sputum Color | Measured daily for 90 days | Clear, yellow, brown, white, none |
| Peak Flow | Measured daily for 90 days | liters/minute |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Lung transplant | 1 |
Baseline characteristics
| Characteristic | Nasal High Flow With Oxygen |
|---|---|
| Age, Continuous Age | 69.2 years STANDARD_DEVIATION 9.6 |
| GOLD grade at enrollment GOLD 2 | 1 participants |
| GOLD grade at enrollment GOLD 3 | 12 participants |
| GOLD grade at enrollment GOLD 4 | 15 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal High Flow With Oxygen | Use of Oxygen Therapy by HNHF-O2 at Home | 6.8 Hours | Standard Deviation 2.1 |
Secondary
Breathlessness
Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal High Flow With Oxygen | Breathlessness | 4.25 score on a scale | Standard Error 1.1 |
Secondary
Change in 6 Minute Walk Distance
Total distance walked in 6 minutes
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal High Flow With Oxygen | Change in 6 Minute Walk Distance | 18.8 meters | Standard Error 13.6 |
Secondary
Spirometry
Change in FEV1
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal High Flow With Oxygen | Spirometry | 0.07 Liters | Standard Deviation 0.6 |
Other Pre-specified
Body Temperature > 100 Degrees F
Yes/no Subjects recorded body temperature via thermometer
Time frame: Measured daily for 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasal High Flow With Oxygen | Body Temperature > 100 Degrees F | 15.9 percentage of days with fever reported |
Other Pre-specified
Peak Flow
liters/minute
Time frame: Measured daily for 90 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nasal High Flow With Oxygen | Peak Flow | 243 Liters/minute |
Other Pre-specified
Polysomnography
Sleep efficiency (percent of time sleeping/total amount of time in bed)
Time frame: 70 days
Other Pre-specified
Polysomnography
Total sleep time in hours
Time frame: 70 days
Other Pre-specified
Polysomnography
Pulse oximetry
Time frame: 70 days
Other Pre-specified
Polysomnography
Heart rate
Time frame: 70 days
Other Pre-specified
Presence of Cough
Yes/no
Time frame: Measured daily for 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Presence of Cough | Yes | 9 Participants |
| Nasal High Flow With Oxygen | Presence of Cough | No | 19 Participants |
Other Pre-specified
Presence of Nasal Congestion
Yes/no
Time frame: Measured daily for 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Presence of Nasal Congestion | Yes | 4 Participants |
| Nasal High Flow With Oxygen | Presence of Nasal Congestion | No | 24 Participants |
Other Pre-specified
Presence of Sore Throat
Yes/no
Time frame: Measured daily for 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Presence of Sore Throat | Yes | 4 Participants |
| Nasal High Flow With Oxygen | Presence of Sore Throat | No | 24 Participants |
Other Pre-specified
Presence of Wheeze
Yes/no
Time frame: Measured daily for 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Presence of Wheeze | Yes | 13 Participants |
| Nasal High Flow With Oxygen | Presence of Wheeze | No | 15 Participants |
Other Pre-specified
Sputum Color
Clear, yellow, brown, white, none
Time frame: Measured daily for 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Sputum Color | None | 12 Participants |
| Nasal High Flow With Oxygen | Sputum Color | White | 8 Participants |
| Nasal High Flow With Oxygen | Sputum Color | Yellow | 3 Participants |
| Nasal High Flow With Oxygen | Sputum Color | Brown | 1 Participants |
| Nasal High Flow With Oxygen | Sputum Color | Green | 1 Participants |
Other Pre-specified
Sputum Consistency
Watery, thin, thick, none, no report made
Time frame: Measured daily for 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Sputum Consistency | None | 838 Daily reports made |
| Nasal High Flow With Oxygen | Sputum Consistency | Thick | 543 Daily reports made |
| Nasal High Flow With Oxygen | Sputum Consistency | Thin | 545 Daily reports made |
| Nasal High Flow With Oxygen | Sputum Consistency | Watery | 182 Daily reports made |
| Nasal High Flow With Oxygen | Sputum Consistency | No report made | 412 Daily reports made |
Other Pre-specified
Sputum Quantity
Volume of sputum
Time frame: Measured daily for 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nasal High Flow With Oxygen | Sputum Quantity | 1 tbsp or more | 11 Participants |
| Nasal High Flow With Oxygen | Sputum Quantity | 1/4 cup or more | 2 Participants |
| Nasal High Flow With Oxygen | Sputum Quantity | No sputum | 15 Participants |