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Randomized cross-over trial of demand oxygen delivery system

Randomized cross-over trial of demand oxygen delivery system in HOT patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052190041
Enrollment
26
Registered
2019-08-23
Start date
2019-10-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease, interstitial pneumonia COPD, IP

Interventions

Arm A: Auto-demand oxygen delivery and then demand oxygen delivery Arm B: Demand oxygen delivery and then auto-demand oxygen delivery

Sponsors

Nishimura Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
mean SpO2

Secondary

MeasureTime frame
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

Contacts

Public ContactTakehiro Otoshi

Kobe University Hosipital

takehiro.otoshi19850902@gmail.com+81-78-382-5660

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026