Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

NCT ID: NCT04481295

Last Updated: 2023-03-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-18

Study Completion Date

2025-07-31

Brief Summary

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The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary 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. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear.

The present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.

Conditions

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High-flow Nasal Cannula Exercise Capacity Chronic Respiratory Failure Optimal SpO2 Value

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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High SpO2 group

In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).

Group Type ACTIVE_COMPARATOR

High-flow nasal cannula

Intervention Type OTHER

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.

Low SpO2 group

In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).

Group Type ACTIVE_COMPARATOR

Low SpO2

Intervention Type OTHER

Low SpO2

Interventions

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High-flow nasal cannula

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 OTHER

Low SpO2

Low SpO2

Intervention Type OTHER

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, liver disease, neurological disease, and renal failure.
* Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month.
* Subjects with changes in LTOT prescription flow within the last month
* Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 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 RECRUITING

Countries

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Japan

Central Contacts

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Yuichi Chihara

Role: CONTACT

81-774-52-0065

Facility Contacts

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Yuichi Chihara, MD., PhD.

Role: primary

81-774-52-0065

Other Identifiers

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2019-24

Identifier Type: -

Identifier Source: org_study_id

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