Which monitor is superior to detect apnea of a healthy adult volunteer between using respiratory sound and plethysmography?

UMIN ID: UMIN000021631

Registered date:01/04/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy adult volunteers
• Date of first enrollment: 2016/04/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The volunteers are applied sensors of Masimo New Radical-7 and Nellcor PM1000N. They breathe at the rate of 12/min by the metronome for 3 min and then they stop breathing for 15-30 sec. If apnea is detected by either the monitor, breathing is resumed. When they feel dyspnea, they may resume breathing. We record below. Time until apnea alarm after the volunteer stop regular breathing. Time until showing respiratory rate on the monitor, and diminished alarm when they resume breathing. RR, oxygen saturation and pulse rate every 30 seconds. Research time is about 15 minutes.

Outcome(s)

• Primary Outcome: Time until detecting apnea by either the monitor after the volunteer stop regular breathing.
• Secondary Outcome: Respiratory rate(RR) during regular breathing Time until showing RR and diminished alarm of the monitor Change of oxygen saturation by apnea

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: A subject shows respiratory symptom at research time.

Related Information

• Primary Sponsor: Tokyo Women's Medical University, School of medicine
• Source(s) of Monetary Support: Tokyo Women's Medical University, School of medicine