Intraoperative, Temperature Monitoring
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMoni-Patc Temperature Monitoring Patch System
A 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).
Sponsors
Murata Vios, Inc.
University of Minnesota
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. 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. 3. Subjects are expected to remain hospitalized at least overnight after surgery. 4. Subject specifically agrees to temperature Sensor placement on the neck prior to surgery. 5. 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). 6. Use environment must meet both of the following parameters: 1. Temperature 15-40⁰ C/59-104⁰ F 2. Humidity 30-75% RH (non-condensing) 7. For non-English speaking subjects, a translator must be present at the time of consent.
Exclusion criteria
1. Subjects unable to provide their own consent. Consent from family or LOR is not acceptable. 2. Subjects undergoing surgical procedures who have conditions of the esophagus or bladder that contraindicate placement of these monitoring probes/sensor. 3. Subjects whose surgery does not involve the monitoring of esophageal or bladder temperature. 4. Subjects undergoing surgery that prohibits placement of an esophageal temperature monitoring probe/sensor (e.g. neck surgery). 5. Subjects with medical conditions such as inflammation, scratches, redness, rash at the Sensor placement site. 6. Subjects for whom the sensor cannot be securely adhered to the skin without floating or detaching, or accurately positioned over the carotid artery. 7. Not for use in MRI or CT facilities. 8. Use environment does not meet one or more parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Moni-Patch™ Temperature Monitoring Patch System and Esophageal (Teso) and Bladder (Tbld) Core Temperature Measurements | Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry. | 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) |
Contacts
CONTACTAsh Shibata Senior Manager
Outcome results
None listed