Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation

NCT04481295 | Unknown

• 1 other identifier: 2019-24
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

HFNC; 6MWD

Outcome Measures

Primary Outcomes (1)

• Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation

  four weeks

Secondary Outcomes (9)

• Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation

  four weeks

• Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation

  four weeks

• Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation

  four weeks

• Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation

  four weeks

• Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation

  four weeks

Study Arms (2)

High SpO2 group

ACTIVE COMPARATOR

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).

Other: High-flow nasal cannula

Low SpO2 group

ACTIVE COMPARATOR

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).

Other: Low SpO2

Interventions

High-flow nasal cannula 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.

High SpO2 group

Low SpO2 OTHER

Low SpO2

Low SpO2 group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Hospital Organization Minami Kyoto Hospital: lead

Study Sites (1)

National Hospital Organization Minami Kyoto Hospital

Jōyō, Kyoto, 610-0113, Japan

RECRUITING

Central Study Contacts

Yuichi Chihara

CONTACT

81-774-52-0065; yc.r03107@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 22, 2020
• Study Start: July 18, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

JP (1)