Nasal High Flow Therapy 30 Day Readmission Study

Fisher and Paykel Healthcare29 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease COPD

Interventions

NHF with or without OxygenDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Alana HealthCare

Liverpool, New York, United States

Medical Research Institute of New Zealand

Wellington, New Zealand

Outcomes

Primary Outcomes

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

Time frame: 30 days after hospital discharge

Secondary Outcomes

Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home

Time frame: 30 days after hospital discharge

Average Use Per Day of the myAIRVO 2 During Week 1

Time frame: First week after hospital discharge

Average Use Per Day of the myAIRVO 2 During Week 2

Time frame: Second week after hospital discharge

Average Use Per Day of the myAIRVO 2 During Week 3

Time frame: Third week after hospital discharge

Average Use Per Day of the myAIRVO 2 During Week 4

Time frame: Fourth week after hospital discharge

Average Use Per Day on Days of myAIRVO 2 Use

Time frame: 30 days after hospital discharge

Number of Participants Using Home Oxygen

Time frame: 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

Time frame: 30 days after hospital discharge

Number of Participants Who Where Screened But Were Excluded From Enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 30 days after hospital discharge

Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting

Time frame: 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

Time frame: At study completion

Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge

Time frame: 30 days after hospital discharge

Reasons for Hospital Admissions

AECOPD, other respiratory cause or other cause

Time frame: 30 days after hospital discharge

In Those That Had at Least One Hospital Readmission: Number of Readmissions

Time frame: 30 days after hospital discharge

In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission

Time frame: 30 days after hospital discharge

In Those That Had at Least One Hospital Readmission: Hospital Readmission Length

Time frame: 30 days after hospital discharge

Number of Participants With at Least One ED Visit Within 30 Days of Discharge

Time frame: 30 days after hospital discharge

Reason for ED Visits

ED visit due to AECOPD

Time frame: 30 days after hospital discharge

Number of Participants With at Least One GP Visit Within 30 Days of Discharge

Time frame: 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.

Time frame: 30 days after hospital discharge

FEV1 at Day 1 and 31

FEV1 change from day 1 to day 31

Time frame: 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

Time frame: 1st and 31st day after hospital discharge

FVC Change From Day 1 to Day 31

Time frame: 1st and 31st day after hospital discharge