Not provided
Not provided
Not provided
Not provided
Study terminated due to change in business of US site.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical Research Institute of New Zealand | OTHER |
| Alana Healthcare | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHF with or without Oxygen | Experimental | NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHF with or without Oxygen | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Fingleton, MBChB | Medical Research Institute of New Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alana HealthCare | Liverpool | New York | 13088 | United States | ||
| Medical Research Institute of New Zealand |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NHF With or Without Oxygen | Patients with or without an existing Oxygen prescription will receive NHF using myAIRVO™ 2. NHF with supplemental Oxygen will be given to participants with an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. NHF without supplemental Oxygen will be given to participants who do not have an oxygen prescription using myAIRVO™ 2: NHF will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | 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. | Posted | Mean | Standard Deviation | hours per day | 30 days after hospital discharge |
|
Over 31 days (1 month)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General unwellness/tired | General disorders | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Stanislav Tatkov | Fisher and Paykel Healthcare | 09 5740100 | stanislav.tatkov@fphcare.co.nz |
Not provided
| 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 | Nov 20, 2015 | Jul 19, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Where Screened But Were Excluded From Enrollment | 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 | Number of participants who withdrew from study after enrollment, up to 30 days | At study completion |
| Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge | 30 days after hospital discharge |
| Reasons for Hospital Admissions | AECOPD, other respiratory cause or other cause | 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 | ED visit due to AECOPD | 30 days after hospital discharge |
| Number of Participants With at Least One GP Visit Within 30 Days of Discharge | 30 days after hospital discharge |
| 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. | 30 days after hospital discharge |
| FEV1 at Day 1 and 31 | FEV1 change from day 1 to day 31 | 1st and 31st day after hospital discharge |
| SVC(in) at Day 1 and 31 | Slow Vital Capacity (inspiratory) change from day 1 to day 31 | 1st and 31st day after hospital discharge |
| FVC Change From Day 1 to Day 31 | 1st and 31st day after hospital discharge |
| Wellington |
| 6242 |
| New Zealand |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home | Posted | Number | percentage of days of use | 30 days after hospital discharge |
|
|
|
| Secondary | Average Use Per Day of the myAIRVO 2 During Week 1 | Posted | Mean | Standard Deviation | hours per day | First week after hospital discharge |
|
|
|
| Secondary | Average Use Per Day of the myAIRVO 2 During Week 2 | Posted | Mean | Standard Deviation | hours per day | Second week after hospital discharge |
|
|
|
| Secondary | Average Use Per Day of the myAIRVO 2 During Week 3 | Posted | Mean | Standard Deviation | hours per day | Third week after hospital discharge |
|
|
|
| Secondary | Average Use Per Day of the myAIRVO 2 During Week 4 | Posted | Mean | Standard Deviation | hours per day | Fourth week after hospital discharge |
|
|
|
| Secondary | Average Use Per Day on Days of myAIRVO 2 Use | Posted | Mean | Standard Deviation | hours per day on days of myAIRVO 2 use | 30 days after hospital discharge |
|
|
|
| Secondary | Number of Participants Using Home Oxygen | Posted | Count of Participants | Participants | At study entry |
|
|
|
| Secondary | Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | Number of Participants Who Where Screened But Were Excluded From Enrollment | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| 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 | Posted | Count of Participants | Participants | At study completion |
|
|
|
| Secondary | Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | Reasons for Hospital Admissions | AECOPD, other respiratory cause or other cause | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | In Those That Had at Least One Hospital Readmission: Number of Readmissions | Posted | Number | readmission/participant | 30 days after hospital discharge |
|
|
|
| Secondary | In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission | Posted | Mean | Standard Deviation | days | 30 days after hospital discharge |
|
|
|
| Secondary | In Those That Had at Least One Hospital Readmission: Hospital Readmission Length | Posted | Mean | Standard Deviation | days | 30 days after hospital discharge |
|
|
|
| Secondary | Number of Participants With at Least One ED Visit Within 30 Days of Discharge | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | Reason for ED Visits | ED visit due to AECOPD | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| Secondary | Number of Participants With at Least One GP Visit Within 30 Days of Discharge | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 30 days after hospital discharge |
|
|
|
| Secondary | FEV1 at Day 1 and 31 | FEV1 change from day 1 to day 31 | Posted | Mean | Standard Deviation | litres per min | 1st and 31st day after hospital discharge |
|
|
|
| Secondary | SVC(in) at Day 1 and 31 | Slow Vital Capacity (inspiratory) change from day 1 to day 31 | Posted | Mean | Standard Deviation | litres per min | 1st and 31st day after hospital discharge |
|
|
|
| Secondary | FVC Change From Day 1 to Day 31 | Posted | Mean | Standard Deviation | litres per min | 1st and 31st day after hospital discharge |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 10 |
| 29 |
| Headache | General disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oral thrush | Infections and infestations | Non-systematic Assessment |
|
| AECOPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |