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

JRCT ID: jRCTs052190042

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: 20
• Study type: Interventional

Intervention(s)

Arm A: Auto-demand oxygen delivery during sleeping and then Continuous flow oxygen during sleeping
Arm B: Continuous flow oxygen during sleeping and then Auto-demand oxygen delivery during sleeping

Outcome(s)

• Primary Outcome: nocturnal mean SpO2
• Secondary Outcome: 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

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. Ambulatory patients with portable device
4. Written informed consent
5. More than 20 years old

Exclude 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

Related Information

• Primary Sponsor: Nagano Tatsuya
• Source(s) of Monetary Support: Teijin Pharma