Moni-Patch temperature data collection during surgery to help build its estimation algorithm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center study enrolling about 30 adults undergoing elective surgery with general anesthesia lasting at least 120 minutes. The Moni-Patch will be placed on the neck over the carotid area and will wirelessly transmit data to a PC-based logger. Esophageal temperature will be monitored as part of routine care. Temperature readings and related perioperative information will be collected to identify opportunities to refine the Moni-Patch algorithm; no formal clinical accuracy criteria or pass/fail metrics are planned. Moni-Patch readings will not be used to guide clinical care, and data collection focuses on algorithm development and internal feasibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adults aged 18 years or older.

Patients scheduled for elective surgery under general anesthesia expected to last at least 120 minutes.

Patients for whom continuous esophageal temperature monitoring is planned as part of routine clinical care.

Patients able to provide their own written informed consent and who agree to Moni-Patch sensor placement on the neck before surgery.

Patients in whom the Moni-Patch sensor can be securely attached over the carotid artery without interfering with the surgical field or wireless connection to the data logger.

Patients undergoing procedures in an environment meeting the device operating requirements of 15-40°C and 30-75% relative humidity.

For non-English-speaking patients, a translator must be available during the informed consent process.

Exclusion Criteria:

Patients unable to provide their own informed consent.

Patients with esophageal conditions contraindicating placement of an esophageal temperature probe.

Patients whose planned procedures do not include esophageal temperature monitoring.

Patients undergoing procedures that prevent placement of the required esophageal temperature probe.

Patients with skin inflammation, scratches, redness, rash, or other conditions at the Moni-Patch placement site.

Patients in whom the Moni-Patch sensor cannot be securely attached or accurately positioned over the carotid artery.

Patients undergoing procedures involving MRI or CT environments where device use is prohibited by the protocol.

Patients for whom device operating environment requirements cannot be met.

Where it's running

• University of Minnesota Medical Center
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Ash Shibata
• Email: a.shibata@murata.com
• Phone: 6124977397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.