Chronic Obstructive Pulmonary Disease, COPD
Conditions
Brief summary
The aim of this feasibility study is to provide data for a subsequent randomized controlled trial to investigate if patient outcomes will be improved after an acute COPD exacerbation using domiciliary nasal high flow therapy (NHF) compared to standard care. This feasibility study will investigate the following: process, resources, management and scientific aspects of delivering NHF as an adjunct therapy in COPD patients.
Interventions
DEVICENHF with or without Oxygen
NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
Sponsors
Medical Research Institute of New Zealand
Alana Healthcare
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Male and female * Admitted to the respiratory ward(s) of either recruiting hospitals with AECOPD as the primary diagnostic reason for admission.
Exclusion criteria
* Given a new home oxygen therapy prescription during the current hospital admission * The investigator believes the participant or their care giver will be unable to safely use the myAIRVO 2 device following discharge * They have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NHF Use for 30 Days Following Discharge After AECOPD | 30 days after hospital discharge | Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home | 30 days after hospital discharge | — |
| Average Use Per Day of the myAIRVO 2 During Week 1 | First week after hospital discharge | — |
| Average Use Per Day of the myAIRVO 2 During Week 2 | Second week after hospital discharge | — |
| Average Use Per Day of the myAIRVO 2 During Week 3 | Third week after hospital discharge | — |
| Average Use Per Day of the myAIRVO 2 During Week 4 | Fourth week after hospital discharge | — |
| Average Use Per Day on Days of myAIRVO 2 Use | 30 days after hospital discharge | — |
| Number of Participants Using Home Oxygen | At study entry | — |
| Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow | 30 days after hospital discharge | — |
| Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting | 30 days after hospital discharge | — |
| Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days | At study completion | Number of participants who withdrew from study after enrollment, up to 30 days |
| Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge | 30 days after hospital discharge | — |
| Number of Participants Who Where Screened But Were Excluded From Enrollment | 30 days after hospital discharge | — |
| In Those That Had at Least One Hospital Readmission: Number of Readmissions | 30 days after hospital discharge | — |
| In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission | 30 days after hospital discharge | — |
| In Those That Had at Least One Hospital Readmission: Hospital Readmission Length | 30 days after hospital discharge | — |
| Number of Participants With at Least One ED Visit Within 30 Days of Discharge | 30 days after hospital discharge | — |
| Reason for ED Visits | 30 days after hospital discharge | ED visit due to AECOPD |
| Number of Participants With at Least One GP Visit Within 30 Days of Discharge | 30 days after hospital discharge | — |
| LACE Index for Hospital Admissions | 30 days after hospital discharge | The LACE Index is a scoring tool for assessing the likelihood of readmission or death within 30 days of discharge. It is based of 4 parameters: length of stay (L), acuity of the admission (A), co-morbidities (C), number of Emergency Department visits within the last 6 months (E). Sub scores for each parameter are summed to give a LACE score ranging from 1 to 19. A score of 0 to 4 = Low; 5 to 9 = Moderate; and a score of ≥ 10 = High risk of readmission. |
| FEV1 at Day 1 and 31 | 1st and 31st day after hospital discharge | FEV1 change from day 1 to day 31 |
| SVC(in) at Day 1 and 31 | 1st and 31st day after hospital discharge | Slow Vital Capacity (inspiratory) change from day 1 to day 31 |
| FVC Change From Day 1 to Day 31 | 1st and 31st day after hospital discharge | — |
| Reasons for Hospital Admissions | 30 days after hospital discharge | AECOPD, other respiratory cause or other cause |
Countries
New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NHF With or Without Oxygen NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge
NHF with or without Oxygen: NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Day 1 SpO2 > 96% | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | NHF With or Without Oxygen |
|---|---|
| Age, Continuous | 67.34 years STANDARD_DEVIATION 10.92 |
| Race/Ethnicity, Customized Maori | 1 Participants |
| Race/Ethnicity, Customized NZ European | 16 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Region of Enrollment New Zealand | 20 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 10 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
NHF Use for 30 Days Following Discharge After AECOPD
Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring
Time frame: 30 days after hospital discharge
Population: NHF use for 30 days following discharge after AECOPD. Use will be expressed as hours of myAIRVO 2 use per day over 30 days, as obtained by myAIRVO 2 electronic monitoring.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | NHF Use for 30 Days Following Discharge After AECOPD | 2.6560 hours per day | Standard Deviation 2.4137 |
Secondary
Average Use Per Day of the myAIRVO 2 During Week 1
Time frame: First week after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | Average Use Per Day of the myAIRVO 2 During Week 1 | 3.0319 hours per day | Standard Deviation 3.7065 |
Secondary
Average Use Per Day of the myAIRVO 2 During Week 2
Time frame: Second week after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | Average Use Per Day of the myAIRVO 2 During Week 2 | 1.7715 hours per day | Standard Deviation 2.236 |
Secondary
Average Use Per Day of the myAIRVO 2 During Week 3
Time frame: Third week after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | Average Use Per Day of the myAIRVO 2 During Week 3 | 2.0447 hours per day | Standard Deviation 2.4633 |
Secondary
Average Use Per Day of the myAIRVO 2 During Week 4
Time frame: Fourth week after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | Average Use Per Day of the myAIRVO 2 During Week 4 | 2.22 hours per day | Standard Deviation 2.69 |
Secondary
Average Use Per Day on Days of myAIRVO 2 Use
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | Average Use Per Day on Days of myAIRVO 2 Use | 3.4326 hours per day on days of myAIRVO 2 use | Standard Deviation 3.4917 |
Secondary
FEV1 at Day 1 and 31
FEV1 change from day 1 to day 31
Time frame: 1st and 31st day after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | FEV1 at Day 1 and 31 | 0.0042 litres per min | Standard Deviation 0.1973 |
Secondary
FVC Change From Day 1 to Day 31
Time frame: 1st and 31st day after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | FVC Change From Day 1 to Day 31 | 0.075 litres per min | Standard Deviation 0.3306 |
Secondary
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | In Those That Had at Least One Hospital Readmission: Hospital Readmission Length | 1 days | Standard Deviation 0 |
Secondary
In Those That Had at Least One Hospital Readmission: Number of Readmissions
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NHF With or Without Oxygen | In Those That Had at Least One Hospital Readmission: Number of Readmissions | 1 readmission/participant |
Secondary
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission | 26 days | Standard Deviation 0 |
Secondary
LACE Index for Hospital Admissions
The LACE Index is a scoring tool for assessing the likelihood of readmission or death within 30 days of discharge. It is based of 4 parameters: length of stay (L), acuity of the admission (A), co-morbidities (C), number of Emergency Department visits within the last 6 months (E). Sub scores for each parameter are summed to give a LACE score ranging from 1 to 19. A score of 0 to 4 = Low; 5 to 9 = Moderate; and a score of ≥ 10 = High risk of readmission.
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | LACE Index for Hospital Admissions | 11.069 scores on a scale | Standard Deviation 1.4188 |
Secondary
Number of Participants Using Home Oxygen
Time frame: At study entry
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants Using Home Oxygen | 7 Participants |
Secondary
Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow | 5 Participants |
Secondary
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting | 9 Participants |
Secondary
Number of Participants Who Where Screened But Were Excluded From Enrollment
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants Who Where Screened But Were Excluded From Enrollment | 0 Participants |
Secondary
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
Number of participants who withdrew from study after enrollment, up to 30 days
Time frame: At study completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days | 10 Participants |
Secondary
Number of Participants With at Least One ED Visit Within 30 Days of Discharge
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants With at Least One ED Visit Within 30 Days of Discharge | 1 Participants |
Secondary
Number of Participants With at Least One GP Visit Within 30 Days of Discharge
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants With at Least One GP Visit Within 30 Days of Discharge | 4 Participants |
Secondary
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge | 2 Participants |
Secondary
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NHF With or Without Oxygen | Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home | 57.6 percentage of days of use |
Secondary
Reason for ED Visits
ED visit due to AECOPD
Time frame: 30 days after hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NHF With or Without Oxygen | Reason for ED Visits | 1 Participants |
Secondary
Reasons for Hospital Admissions
AECOPD, other respiratory cause or other cause
Time frame: 30 days after hospital discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NHF With or Without Oxygen | Reasons for Hospital Admissions | AECOPD | 2 Participants |
| NHF With or Without Oxygen | Reasons for Hospital Admissions | Other Respiratory | 0 Participants |
| NHF With or Without Oxygen | Reasons for Hospital Admissions | Non-respiratory | 0 Participants |
Secondary
SVC(in) at Day 1 and 31
Slow Vital Capacity (inspiratory) change from day 1 to day 31
Time frame: 1st and 31st day after hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NHF With or Without Oxygen | SVC(in) at Day 1 and 31 | 0.0027 litres per min | Standard Deviation 0.393 |