Moni-Patc Temperature Monitoring Patch System, a non-invasive, continuous temperature monitoring device designed to estimate core body temperature by applying a Sensor to the neck.This clinical accuracy validation study aims to verify the accuracy and repeatability of the Moni-Patch compared with an FDA-cleared continuous esophageal and bladder temperature monitoring device used as the clinical reference.Main ObjectivesTo verify that the Moni-Patch and the reference device(esophageal and bladder) demonstrate acceptable agreement, as defined by Bland-Altman Analyses (bias within ±0.4°C and limits of agreement between -1.0°C and 1.0°C).To verify the consistency and repeatability of temperature measurements obtained from the Moni-Patch during continuous monitoring.
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.
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).
The study population consists of adult patients aged 18 years and older who are undergoing elective surgical procedures under general anesthesia in the operating room. Eligible participants are those for whom continuous esophageal and bladder temperature monitoring is clinically indicated as part of routine perioperative care and who are expected to remain hospitalized overnight following surgery. Participants will have the Moni-Patch Temperature Monitoring Patch System applied to the neck for continuous, non-invasive temperature monitoring during surgery. The study population will include a range of body mass index (BMI) categories to support evaluation of device performance across different body habitus. Subjects must be able to provide informed consent and meet environmental and clinical conditions required for use of the study device.
Case-only
Prospective
Moni-Patc Temperature Monitoring Patch System
DeviceA non-sterile, non-invasive temperature monitoring system applied to the neck; Bluetooth 5.0 transmission to a receiver; continuous core temperature estimation using dual heat-flux/thermistor-based algorithm; conforms to ISO 80601-2-56 (25-42 °C).
Agreement Between Moni-Patch™ Temperature Monitoring Patch System and Esophageal (Teso) and Bladder (Tbld) Core Temperature Measurements
This outcome assesses agreement between the Moni-Patch™ Temperature Monitoring Patch System and clinical reference core temperature measurements obtained using FDA-cleared esophageal temperature probes (Teso) and FDA-cleared bladder temperature probes (Tbld) during general anesthesia. Paired temperature values are collected simultaneously from: Moni-Patch™ Sensor (neck placement) Esophageal core temperature probe (Teso) Bladder core temperature probe (Tbld) Agreement is evaluated using Bland-Altman analysis, including: Mean temperature difference (bias; °C) 95% limits of agreement (LOA; °C) Name of Measurement: Core temperature difference (Moni-Patch - Teso; Moni-Patch - Tbld) Measurement Tools: Moni-Patch™ Temperature Monitoring Patch System FDA-cleared esophageal core temperature monitor (Teso) FDA-cleared bladder core temperature monitor (Tbld) Unit of Measure: Degrees Celsius (°C)
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Murata Vios, Inc.
Lead sponsor
University of Minnesota
Collaborator
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