Analysis of the Efficacy and Stability of a Wearable ECG Monitor

Официальное название

Analysis of the Efficacy and Stability of a Single-Channel Patch-Type Wearable Electrocardiogram Monitor

Обзор

This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring

Подробное описание

This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring. After the data collection is completed, a satisfaction survey will be conducted with the medical staff. The data obtained simultaneously from HiCardi+ and MX40 will be analyzed, and the satisfaction survey responses from the medical staff will be reviewed to confirm the clinical convenience of the patch-type ECG monitoring device.

Вмешательства

• Устройство ECG monitoring by telemetry device and patch-type ECG monitor at the same time
  The patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph.

Первичные конечные точки

• The number of total QRS complex [Срок оценки: Within 3 months after electrocardiogram monitoring procedure]
• The rate of signal loss [Срок оценки: Within 3 months after electrocardiogram monitoring procedure]

Вторичные конечные точки (3)

• Average heart rate [Срок оценки: Within 3 months after electrocardiogram monitoring procedure]
• The number of arrhythmia and technical alarm [Срок оценки: Within 3 months after electrocardiogram monitoring procedure]
• Results of satisfaction survey [Срок оценки: Within 3 months after electrocardiogram monitoring procedure]

Критерии участия

Критерии включения

• Adults aged 19 years or older
• Patients admitted to Chonnam National University Hospital who require ECG monitoring
• Individuals who have expressed their intention to participate in this study or have obtained written consent from a proxy

Критерии исключения

• Individuals who are unable to provide consent themselves or through a legally designated representative
• Individuals deemed unsuitable for participation in the clinical trial based on the researcher's judgment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Choi W, Kim SH, Lee W, Kang SH, Yoon CH, Youn TJ, Chae IH. Comparison of Continuous ECG Monitoring by Wearable Patch Device and Conventional Telemonitoring Device. J Korean Med Sci. 2020 Nov 16;35(44):e363. doi: 10.3346/jkms.2020.35.e363. PMID 33200590
• Kwon S, Choi EK, Lee SR, Oh S, Song HS, Lee YS, Han SJ, Lim HE. Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System. Korean Circ J. 2024 Mar;54(3):140-153. doi: 10.4070/kcj.2023.0252. PMID 38506104
• Marouf M, Vukomanovic G, Saranovac L, Bozic M. Multi-purpose ECG telemetry system. Biomed Eng Online. 2017 Jun 19;16(1):80. doi: 10.1186/s12938-017-0371-6. PMID 28629374
• Nelson BW, Allen NB. Accuracy of Consumer Wearable Heart Rate Measurement During an Ecologically Valid 24-Hour Period: Intraindividual Validation Study. JMIR Mhealth Uhealth. 2019 Mar 11;7(3):e10828. doi: 10.2196/10828. PMID 30855232

Идентификаторы

NCT: NCT06546046 · CDV-2024-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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