Меню
Набор скоро начнётся NCT07397065

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

— Наблюдательное Temperature Monitoring Intraoperative

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Moni-Patc Temperature Monitoring Patch System.
Кому может быть актуально
Состояния в реестре: Temperature Monitoring, Intraoperative. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Moni-Patc Temperature Monitoring Patch System Clinical Accuracy Validation

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Moni-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).

Первичные конечные точки

  • Agreement Between Moni-Patch™ Temperature Monitoring Patch System and Esophageal (Teso) and Bladder (Tbld) Core Temperature Measurements [Срок оценки: Continuous intra-operative monitoring for ≥60 minutes, beginning after ≥30 minutes of Moni-Patch sensor acclimation prior to operating room entry.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07397065 · MM-MPS2-0001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗