Nasal High Flow Therapy 30 Day Readmission Study (N3ADS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Intervention / Treatment: Device: NHF with or without Oxygen

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Wellington, New Zealand, 6242
    • Medical Research Institute of New Zealand
• United States
  • New York
    • Liverpool, New York, United States, 13088
      • Alana HealthCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Collaborators: Medical Research Institute of New Zealand; Alana Healthcare
• Investigators: Principal Investigator: James Fingleton, MBChB, Medical Research Institute of New Zealand

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): May 3, 2017

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CIA138