Clinical trial NCT02552732: Nasal High Flow Therapy 30 Day Readmission Study
Official title: Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Medical Research Institute of New Zealand
name: Alana Healthcare
First posted: 2015-09-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: NHF Use for 30 Days Following Discharge After AECOPD
timeFrame: 30 days after hospital discharge
Secondary outcomes:
measure: Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
timeFrame: 30 days after hospital discharge
measure: Average Use Per Day of the myAIRVO 2 During Week 1
timeFrame: First week after hospital discharge
measure: Average Use Per Day of the myAIRVO 2 During Week 2
timeFrame: Second week after hospital discharge
measure: Average Use Per Day of the myAIRVO 2 During Week 3
timeFrame: Third week after hospital discharge
measure: Average Use Per Day of the myAIRVO 2 During Week 4
timeFrame: Fourth week after hospital discharge
measure: Average Use Per Day on Days of myAIRVO 2 Use
timeFrame: 30 days after hospital discharge
measure: Number of Participants Using Home Oxygen
timeFrame: At study entry
measure: Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow
timeFrame: 30 days after hospital discharge
measure: Number of Participants Who Where Screened But Were Excluded From Enrollment
timeFrame: 30 days after hospital discharge
measure: Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
timeFrame: 30 days after hospital discharge
measure: Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
timeFrame: At study completion
measure: Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
timeFrame: 30 days after hospital discharge
measure: Reasons for Hospital Admissions
timeFrame: 30 days after hospital discharge
measure: In Those That Had at Least One Hospital Readmission: Number of Readmissions
timeFrame: 30 days after hospital discharge
measure: In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
timeFrame: 30 days after hospital discharge
measure: In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
timeFrame: 30 days after hospital discharge
measure: Number of Participants With at Least One ED Visit Within 30 Days of Discharge
timeFrame: 30 days after hospital discharge
measure: Reason for ED Visits
timeFrame: 30 days after hospital discharge
measure: Number of Participants With at Least One GP Visit Within 30 Days of Discharge
timeFrame: 30 days after hospital discharge
measure: LACE Index for Hospital Admissions
timeFrame: 30 days after hospital discharge
measure: FEV1 at Day 1 and 31
timeFrame: 1st and 31st day after hospital discharge
measure: SVC(in) at Day 1 and 31
timeFrame: 1st and 31st day after hospital discharge
measure: FVC Change From Day 1 to Day 31
timeFrame: 1st and 31st day after hospital discharge
Other outcomes:
Locations:
city: Liverpool
country: United States
facility: Alana HealthCare
state: New York
city: Wellington
country: New Zealand
facility: Medical Research Institute of New Zealand
Study officials:
affiliation: Medical Research Institute of New Zealand
name: James Fingleton, MBChB
role: PRINCIPAL_INVESTIGATOR
References: