Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

National Hospital Organization Minami Kyoto Hospital

Status: Enrolling

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

Treatments: Other: Low SpO2; Other: High-flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04481295

2019-24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

High SpO2 group

Active Comparator group

Description:

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).

Treatment:

Other: High-flow nasal cannula

Low SpO2 group

Active Comparator group

Description:

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).

Treatment:

Other: Low SpO2