Randomized cross-over trial of demand oxygen delivery system

JRCT ID: jRCTs052190041

Registered date:23/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic obstructive pulmonary disease, interstitial pneumonia
• Date of first enrollment: 04/10/2019
• Target sample size: 26
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: mean SpO2
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Nishimura Yoshihiro
• Source(s) of Monetary Support: Teijin Pharma