Nasal High Flow Therapy 30 Day Readmission Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— N3ADS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02552732
• Other study ID #: CIA138
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 3, 2017

Study information

• Verified date: August 2020
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
New Zealand	Medical Research Institute of New Zealand	Wellington
United States	Alana HealthCare	Liverpool	New York

Sponsors (3)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	Alana Healthcare, Medical Research Institute of New Zealand

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home		30 days after hospital discharge
Secondary	Average Use Per Day of the myAIRVO 2 During Week 1		First week after hospital discharge
Secondary	Average Use Per Day of the myAIRVO 2 During Week 2		Second week after hospital discharge
Secondary	Average Use Per Day of the myAIRVO 2 During Week 3		Third week after hospital discharge
Secondary	Average Use Per Day of the myAIRVO 2 During Week 4		Fourth week after hospital discharge
Secondary	Average Use Per Day on Days of myAIRVO 2 Use		30 days after hospital discharge
Secondary	Number of Participants Using Home Oxygen		At study entry
Secondary	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
Secondary	Number of Participants Who Where Screened But Were Excluded From Enrollment		30 days after hospital discharge
Secondary	Number of Participants Who Reported Having Changed the myAIRVO 2 Temperature Setting From the Initial Setting		30 days after hospital discharge
Secondary	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
Secondary	Number of Participants With at Least One Hospital Readmission Within 30 Days of Discharge		30 days after hospital discharge
Secondary	Reasons for Hospital Admissions	AECOPD, other respiratory cause or other cause	30 days after hospital discharge
Secondary	In Those That Had at Least One Hospital Readmission: Number of Readmissions		30 days after hospital discharge
Secondary	In Those That Had at Least One Hospital Readmission: Time to First Hospital Readmission		30 days after hospital discharge
Secondary	In Those That Had at Least One Hospital Readmission: Hospital Readmission Length		30 days after hospital discharge
Secondary	Number of Participants With at Least One ED Visit Within 30 Days of Discharge		30 days after hospital discharge
Secondary	Reason for ED Visits	ED visit due to AECOPD	30 days after hospital discharge
Secondary	Number of Participants With at Least One GP Visit Within 30 Days of Discharge		30 days after hospital discharge
Secondary	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
Secondary	FEV1 at Day 1 and 31	FEV1 change from day 1 to day 31	1st and 31st day after hospital discharge
Secondary	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
Secondary	FVC Change From Day 1 to Day 31		1st and 31st day after hospital discharge