Nasal High Flow Therapy 30 Day Readmission Study

NCT ID: NCT02552732

Last Updated: 2020-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

NHF with or without Oxygen

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Institute of New Zealand

OTHER

Sponsor Role collaborator

Alana Healthcare

UNKNOWN

Sponsor Role collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Fingleton, MBChB

Role: PRINCIPAL_INVESTIGATOR

Medical Research Institute of New Zealand

Locations

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Alana HealthCare

Liverpool, New York, United States

Site Status

Medical Research Institute of New Zealand

Wellington, , New Zealand

Site Status

Countries

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United States New Zealand

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CIA138

Identifier Type: -

Identifier Source: org_study_id

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