Research on the safety of new heating device

JRCT ID: jRCTs052240041

Registered date:21/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy people
• Date of first enrollment: 21/05/2024
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Four series of experiments will be conducted on one subject: carbon dioxide gas (room temperature/warming) and placebo (room temperature/warming). The evaluation is conducted for a total of 60 minutes, 20 minutes during gas administration and 40 minutes after gas administration ends.

Outcome(s)

Primary Outcome

Measure surface skin temperature every 5 minutes from the start of device use until 40 minutes after device use
Assessment of pain, itching, and sensory abnormality and surface skin temperature of the upper extremity on the side where gas is administered before and immediately after the use of the device (20 minutes) and at the end of the follow-up observation (40 minutes)
Blood pressure, pulse rate, body temperature, SpO2, pCO2 every 5 minutes from the start of device use until 40 minutes after device use
Appearance and severity of nausea, vomiting, fatigue, cough, dyspnea, and palpitations from the start of device use to 40 minutes after device use (CTCAE v5.0)

Secondary Outcome

Blood flow increase rate determined by laser Doppler
Time taken to return to pre-administration values using laser Doppler

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

1. Healthy individuals aged 20 to 50 at the time of consent (those who do not have a specific chronic disease (however, hypertension and diabetes controlled by oral medication are acceptable.) and who do not have any problems with daily activities. )
2. Gender doesn't matter
3. Persons who have given their own voluntary written consent to participate in this clinical research

Exclude criteria

1. People who are deemed unsuitable by the person in charge of this clinical research
2. People with skin diseases on both upper limbs
3. People with a history of serious cardiovascular disease, cerebrovascular disease, or respiratory disease
4. Pregnant women, people who may be pregnant, or people who are breastfeeding
5. Persons who have participated in another clinical trial within the past 4 months

Related Information

• Primary Sponsor: Oe Keisuke
• Secondary Sponsor: Sakai Yoshitada,MINATO MEDICAL SCIENCE CO.,LTD.