Nasal High Flow Therapy 30 Day Readmission Study

Study Overview
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Brief Summary
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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.

Official Title
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Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study

Conditions
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Chronic Obstructive Pulmonary Disease, COPD

Intervention / Treatment
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* Device: NHF with or without Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NHF with or without Oxygen<br>NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge | Device: NHF with or without Oxygen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |