Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia

Phase 1

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

• Registration Number: JPRN-jRCTs052190042
• Lead Sponsor: agano Tatsuya

Brief Summary

The primary endpoint was the mean value of SpO2, but the difference in SpO2 between continuous flow and auto demand was 0.835% (95% confidence interval [0.1334, 1.5366]) in the study based on the difference in timing. The upper limit of the difference did not exceed 2.8, which was set as the non-inferiority margin. Therefore, it was shown that autodemand did not reduce SpO2 by at least 2.8% on average compared to the continuous dose. No equipment failure or exacerbation of disease was observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Study Completion: 2022-09-06
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Home oxygen therapy
2. Chronic obstructive pulmonary disease or interstitial pneumonia
3. Ambulatory patients with portable device
4. Written informed consent
5. More than 20 years old

Exclusion Criteria

1. Noninvasive positive pressure ventilation therapy
2. Continuous Positive Airway Pressure therapy
3. 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)
4. Hemoglobin < 9 g/dL
5. History of acute exacerbation of chronic obstructive pulmonary disease or interstitial pneumonia within 3 months
6. Pregnant women or women who may be pregnant or breastfeeding
7. 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
nocturnal mean SpO2

Secondary Outcome Measures

Name	Time	Method
sensitivity rate (%), the number of times and time that SpO2 became 90% or more, the lowest value of SpO2, Average/High pulse rate, apnea index, Apnea hypopnea index sleeping time, comfortable Degree, reliability