Overview
This study aims to collect synchronized temperature measurements from the Moni-Patch Temperature Monitoring Patch System and an esophageal temperature probe during surgery to support the development and refinement of the Moni-Patch temperature estimation algorithm.
Approximately 30 adult patients undergoing elective surgery under general anesthesia will participate. Moni-Patch will be applied non-invasively to the neck, while esophageal temperature will be monitored as part of routine clinical care.
Temperature data and related perioperative information will be collected for algorithm development and internal feasibility evaluation.
This study is not designed to validate clinical accuracy or assess whether predefined accuracy criteria are met.
Description
This is a prospective, single-center study designed to collect synchronized Moni-Patch and esophageal temperature data for algorithm development and refinement.
Approximately 30 adult patients undergoing elective surgery under general anesthesia lasting at least 120 minutes will be enrolled.
A Moni-Patch sensor will be attached to the skin over the carotid artery in the neck. The sensor will communicate wirelessly with a PC-based data logger to continuously record temperature measurements and device data.
Esophageal temperature will be monitored using a clinically indicated temperature probe connected to the patient monitoring system.
Synchronized temperature data will be collected during surgery. At least 120 minutes of valid simultaneous Moni-Patch and esophageal temperature measurements will be targeted for each participant.
Data collection will also include patient characteristics, surgical and anesthesia information, warming conditions, device-use information, and relevant environmental conditions.
The collected data will be used to identify opportunities for algorithm improvement and to characterize device performance internally. Descriptive analyses may be performed, but no formal clinical accuracy hypothesis test or pass/fail acceptance criterion is planned.
Moni-Patch readings will not be used to guide clinical care.
Eligibility
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.
