Clinical Accuracy Validation of the Moni-Patc Temperature Monitoring Patch During Surgery (Compared With Esophageal and Bladder Temperature)

This single-center, open-label accuracy validation compares continuous core temperature measured by the Moni-Patch applied on the neck with esophageal (T_eso) and bladder (T_bld) temperatures during elective surgeries under general anesthesia. Approximately 30 adult participants will be monitored for ≥60 minutes intraoperatively. Agreement will be assessed using Bland-Altman methods (bias and 95% limits of agreement). The device is non-invasive and Bluetooth-enabled; readings are captured via the receiver and routed to the OR multi-parameter monitor and EMR. Safety monitoring focuses on device-related skin reactions and device deficiencies; no changes to anesthetic care are mandated by the protocol.

Inclusion criteria

• Age ≥18 years
• Subject is undergoing an elective surgical procedure expected to require at least 60min of general anesthesia and during which routine esophageal (Teso) and bladder (Tbld) temperature monitoring is expected.
• Subjects are expected to remain hospitalized at least overnight after surgery.
• Subject specifically agrees to temperature Sensor placement on the neck prior to surgery.
• Must be able to attach the Sensor away from the operative field (neck) with uninterrupted wireless connection between the Sensor and the Receiver (as close as possible).
• Use environment must meet both of the following parameters:

• Temperature 15-40⁰ C/59-104⁰ F
• Humidity 30-75% RH (non-condensing)
• For non-English speaking subjects, a translator must be present at the time of consent.

Exclusion criteria

• Subjects unable to provide their own consent. Consent from family or LOR is not acceptable.
• Subjects undergoing surgical procedures who have conditions of the esophagus or bladder that contraindicate placement of these monitoring probes/sensor.
• Subjects whose surgery does not involve the monitoring of esophageal or bladder temperature.
• Subjects undergoing surgery that prohibits placement of an esophageal temperature monitoring probe/sensor (e.g. neck surgery).
• Subjects with medical conditions such as inflammation, scratches, redness, rash at the Sensor placement site.
• Subjects for whom the sensor cannot be securely adhered to the skin without floating or detaching, or accurately positioned over the carotid artery.
• Not for use in MRI or CT facilities.
• Use environment does not meet one or more parameters.