Analysis of the Efficacy and Stability of a Wearable ECG Monitor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECG monitoring by telemetry device and patch-type ECG monitor at the same time.
- Who it may be relevant to
- Registry conditions: Arrhythmias, Cardiac, Bradycardia, Tachycardia, Atrial Fibrillation. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of the Efficacy and Stability of a Single-Channel Patch-Type Wearable Electrocardiogram Monitor
Overview
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
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- The number of total QRS complex [Time frame: Within 3 months after electrocardiogram monitoring procedure]
- The rate of signal loss [Time frame: Within 3 months after electrocardiogram monitoring procedure]
Secondary outcome measures (3)
- Average heart rate [Time frame: Within 3 months after electrocardiogram monitoring procedure]
- The number of arrhythmia and technical alarm [Time frame: Within 3 months after electrocardiogram monitoring procedure]
- Results of satisfaction survey [Time frame: Within 3 months after electrocardiogram monitoring procedure]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT06546046 · CDV-2024-01