The Efficacy of Nasal High Flow Oxygen Therapy With Rehabilitation in the Patients With Chronic Respiratory Failure

NCT ID: NCT02804243

Last Updated: 2018-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-05-31

Brief Summary

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The purpose of this study is to compare the exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Detailed Description

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In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in chronic obstructive pulmonary disease patients. Recently, nasal high flow therapy which consists of high flow gas with an FiO2 ranging from 0.21 to nearly 1.0 adjusted by an oxygen blender, brought to body temperature, and saturated with water through an in-line humidifier is available.

The present study is randomised to compare the effect of exercise endurance between oxygen therapy with rehabilitation and nasal high flow therapy with rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Conditions

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Chronic Respiratory Failure Nasal High Flow Therapy Rehabilitation Exercise Endurance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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nasal high flow therapy

In this group, patients have undergone rehabilitation under the nasal high flow therapy (FiO2 100%, oxygen flow from 30 to 60 L/min) during four weeks.

Group Type ACTIVE_COMPARATOR

nasal high flow therapy

Intervention Type DEVICE

The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

oxygen therapy

In this group, patients have undergone rehabilitation under the oxygen therapy via a nasal canula (6 L/min) during four weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nasal high flow therapy

The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.

Exclusion Criteria

* Subjects with severe cardiovascular disease, diabetes, neurological disease, and renal failure.
* Subject who are unable to undergo rehabilitation.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hospital Organization Minami Kyoto Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, Japan

Site Status

Countries

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Japan

References

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Chihara Y, Tsuboi T, Sumi K, Sato A. Effectiveness of high-flow nasal cannula on pulmonary rehabilitation in subjects with chronic respiratory failure. Respir Investig. 2022 Sep;60(5):658-666. doi: 10.1016/j.resinv.2022.05.002. Epub 2022 May 26.

Reference Type DERIVED
PMID: 35644803 (View on PubMed)

Other Identifiers

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27-10

Identifier Type: -

Identifier Source: org_study_id

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