Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Algorithm development for Seismocardiograph and Ballistocardiograph for detecting Supraventricular tachycardia
研究概览
简要总结
The aim of this study is to evaluate the reliability of smartphone seismocardiography (SCG) and bed-based ballistocardiography (BCG) for detecting supraventricular tachycardia (SVT) in children aged 0-10 years. The performance of these methods will be compared to the gold standard of continuous telemetry ECG recording.
详细描述
This study aims to validate the use of a cardiac monitoring system, comprising a smartphone for seismocardiography (SCG) and a smart mattress for ballistocardiography (BCG), to detect supraventricular tachycardia (SVT) in children aged 0-10 years. Additionally, the study will compare heart rate and breathing rate measurements from these investigational devices against a Philips Intellivue X2 ECG Monitor, which serves as the gold standard. A convenience sample of up to 60 children (30 in the SVT group and 30 in the control group) will be recruited, and their parents will also be interviewed to explore their perceptions of arrhythmia monitoring. The primary objective is to develop and understand algorithms for differentiating SVT from sinus rhythm using SCG and BCG signals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For children in Study(SVT) group:
- •received informed consent from both parents/guardians
- •the child is treated in the Pediatric wards of Tyks Lighthouse hospital
- •the child is between the age of 0-10 years
- •the child has diagnosed or suspected SVT.
- •For children in control group:
- •received informed consent from both parents/guardians
- •the child is treated in the Pediatric wards of Tyks Lighthouse hospital
- •the child is between the age of 0-10 years
- •child has not diagnosed with SVT
排除标准
- •All participant groups:
- •not reaching the inclusion criteria
研究组 & 干预措施
Study( SVT) Group
Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse Hospital with diagnosed or suspected supraventricular tachycardia (SVT).
干预措施: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings (Diagnostic Test)
Control Group
Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse hospital who have not been diagnosed with SVT (i.e., have a normal sinus rhythm).
干预措施: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings (Diagnostic Test)
结局指标
主要结局
Algorithm development for Seismocardiograph and Ballistocardiograph for detecting Supraventricular tachycardia
时间窗: 2025-2027
Understanding and developing the algorithm to differentiate the supraventricular tachycardia (SVT) and sinus rhythm subjects based on seismocardiography and ballistocardiography signals.
次要结局
未报告次要终点
研究者
Anna Axelin
Professor, Head of Department
University of Turku