Nasal High Flow Therapy 30 Day Readmission Study (N3ADS)

August 6, 2020 updated by: Fisher and Paykel Healthcare

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NHF Use for 30 Days Following Discharge After AECOPD
Time Frame: 30 days after hospital discharge
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Days of Use, Adjusted for Number of Days With myAIRVO 2 at Home
Time Frame: 30 days after hospital discharge
30 days after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 1
Time Frame: First week after hospital discharge
First week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 2
Time Frame: Second week after hospital discharge
Second week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 3
Time Frame: Third week after hospital discharge
Third week after hospital discharge
Average Use Per Day of the myAIRVO 2 During Week 4
Time Frame: Fourth week after hospital discharge
Fourth week after hospital discharge
Average Use Per Day on Days of myAIRVO 2 Use
Time Frame: 30 days after hospital discharge
30 days after hospital discharge
Number of Participants Using Home Oxygen
Time Frame: At study entry
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
30 days after hospital discharge
Number of Participants Who Where Screened But Were Excluded From Enrollment
Time Frame: 30 days after hospital discharge
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
30 days after hospital discharge
Number of Participants Who Withdrew From Study After Enrollment, up to 30 Days
Time Frame: At study completion
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
Time Frame: 30 days after hospital discharge
30 days after hospital discharge
Reasons for Hospital Admissions
Time Frame: 30 days after hospital discharge
AECOPD, other respiratory cause or other cause
30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Number of Readmissions
Time Frame: 30 days after hospital discharge
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
30 days after hospital discharge
In Those That Had at Least One Hospital Readmission: Hospital Readmission Length
Time Frame: 30 days after hospital discharge
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
30 days after hospital discharge
Reason for ED Visits
Time Frame: 30 days after hospital discharge
ED visit due to AECOPD
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
30 days after hospital discharge
LACE Index for Hospital Admissions
Time Frame: 30 days after hospital discharge
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
Time Frame: 1st and 31st day after hospital discharge
FEV1 change from day 1 to day 31
1st and 31st day after hospital discharge
SVC(in) at Day 1 and 31
Time Frame: 1st and 31st day after hospital discharge
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
Time Frame: 1st and 31st day after hospital discharge
1st and 31st day after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fisher and Paykel Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Research Institute of New Zealand
Alana Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Fingleton, MBChB, Medical Research Institute of New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIA138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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