Randomized cross-over trial of demand oxygen delivery system

Phase 1

• Conditions: Chronic obstructive pulmonary disease, interstitial pneumonia; COPD, IP; 071, 066

• Registration Number: JPRN-jRCTs052190041
• Lead Sponsor: ishimura Yoshihiro

Brief Summary

This study has shown that the utility of auto-DODS in maintaining oxygenation at rest and during exercise was equal to that of conventional DODS among patients with chronic respiratory failure. Also, our study showed that failure to trigger the flow sensor at rest by conventional DODS does not affect the oxygenation and that flow sensor can be successfully triggered during exercise in most of the patients by conventional DODS.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Study Completion: 2020-07-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Home oxygen therapy
2. Chronic obstructive pulmonary disease or interstitial pneumonia
3. patients who is able to do 6-Minute Walk Test with portable device
4. Written informed consent
5. More than 20 years old
6. Patients whose respiratory function is expected to be stable during the study participation period including the observation period.

Exclusion Criteria

1. Noninvasive positive pressure ventilation therapy
2. Symptomatic congestive heart failure, unstable angina, history of myocardial infarction within 1 year prior to registration, clinically severe arrhythmia (CLBBB, 2nd and 3rd degree AV block, Vf)
3. History of acute exacerbation of chronic obstructive pulmonary disease or interstitial pneumonia within 3 month
4. Hemoglobin < 9 g/dL
5. Pregnant women or women who may be pregnant or breastfeeding
6. A judgment by the attending physician that patient participation would be inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean SpO2

Secondary Outcome Measures

Name	Time	Method
sensitivity rate (%), the number of times and percentage that SpO2 became 90% or less, the lowest value of SpO2, Averag e /Hig h pulse rate,the distance of 6MWT, the recovery time of 6MWT, Borg scale change, comfortable Deg ree, reliability