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Nasal High Flow Therapy 30 Day Readmission Study (N3ADS)

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NHF with or without Oxygen
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alana HealthCare
  • Medical Research Institute of New Zealand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NHF with or without Oxygen

Arm Description

NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Average Use Per Day of the myAIRVO 2 During Week 1
Average Use Per Day of the myAIRVO 2 During Week 2
Average Use Per Day of the myAIRVO 2 During Week 3
Average Use Per Day of the myAIRVO 2 During Week 4
Average Use Per Day on Days of myAIRVO 2 Use
Number of Participants Using Home Oxygen
Number of Participants Who Reported Having Changed the myAIRVO 2 Flow Settings From the Initial Flow and the Corresponding Reduction in Flow
Number of Participants Who Where Screened But Were Excluded From Enrollment
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
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
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
Reasons for Hospital Admissions
AECOPD, other respiratory cause or other cause
In Those That Had at Least One Hospital Readmission: Number of Readmissions
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Number of Participants With at Least One ED Visit Within 30 Days of Discharge
Reason for ED Visits
ED visit due to AECOPD
Number of Participants With at Least One GP Visit Within 30 Days of 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.
FEV1 at Day 1 and 31
FEV1 change from day 1 to day 31
SVC(in) at Day 1 and 31
Slow Vital Capacity (inspiratory) change from day 1 to day 31
FVC Change From Day 1 to Day 31

Full Information

First Posted
September 15, 2015
Last Updated
August 6, 2020
Sponsor
Fisher and Paykel Healthcare
Collaborators
Medical Research Institute of New Zealand, Alana Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02552732
Brief Title
Nasal High Flow Therapy 30 Day Readmission Study
Acronym
N3ADS
Official Title
Nasal High Flow (NHF) Therapy Use Following Hospitalization for an Exacerbation of COPD: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to change in business of US site.
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 3, 2017 (Actual)
Study Completion Date
May 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
Collaborators
Medical Research Institute of New Zealand, Alana Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NHF with or without Oxygen
Arm Type
Experimental
Arm Description
NHF with or without oxygen will be delivered to COPD patients using myAIRVO™ 2 for 30 days post hospital discharge
Intervention Type
Device
Intervention Name(s)
NHF with or without Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
NHF Use for 30 Days Following Discharge After AECOPD
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Time Frame
30 days after hospital discharge
Title
Average Use Per Day of the myAIRVO 2 During Week 1
Time Frame
First week after hospital discharge
Title
Average Use Per Day of the myAIRVO 2 During Week 2
Time Frame
Second week after hospital discharge
Title
Average Use Per Day of the myAIRVO 2 During Week 3
Time Frame
Third week after hospital discharge
Title
Average Use Per Day of the myAIRVO 2 During Week 4
Time Frame
Fourth week after hospital discharge
Title
Average Use Per Day on Days of myAIRVO 2 Use
Time Frame
30 days after hospital discharge
Title
Number of Participants Using Home Oxygen
Time Frame
At study entry
Title
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
Title
Number of Participants Who Where Screened But Were Excluded From Enrollment
Time Frame
30 days after hospital discharge
Title
Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting
Time Frame
30 days after hospital discharge
Title
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
Description
Number of participants who withdrew from study after enrollment, up to 30 days
Time Frame
At study completion
Title
Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge
Time Frame
30 days after hospital discharge
Title
Reasons for Hospital Admissions
Description
AECOPD, other respiratory cause or other cause
Time Frame
30 days after hospital discharge
Title
In Those That Had at Least One Hospital Readmission: Number of Readmissions
Time Frame
30 days after hospital discharge
Title
In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission
Time Frame
30 days after hospital discharge
Title
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Time Frame
30 days after hospital discharge
Title
Number of Participants With at Least One ED Visit Within 30 Days of Discharge
Time Frame
30 days after hospital discharge
Title
Reason for ED Visits
Description
ED visit due to AECOPD
Time Frame
30 days after hospital discharge
Title
Number of Participants With at Least One GP Visit Within 30 Days of Discharge
Time Frame
30 days after hospital discharge
Title
LACE Index for Hospital Admissions
Description
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
Title
FEV1 at Day 1 and 31
Description
FEV1 change from day 1 to day 31
Time Frame
1st and 31st day after hospital discharge
Title
SVC(in) at Day 1 and 31
Description
Slow Vital Capacity (inspiratory) change from day 1 to day 31
Time Frame
1st and 31st day after hospital discharge
Title
FVC Change From Day 1 to Day 31
Time Frame
1st and 31st day after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Fingleton, MBChB
Organizational Affiliation
Medical Research Institute of New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alana HealthCare
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Medical Research Institute of New Zealand
City
Wellington
ZIP/Postal Code
6242
Country
New Zealand

12. IPD Sharing Statement

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Nasal High Flow Therapy 30 Day Readmission Study

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