Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study

University of Turku

Status: Not yet enrolling

Conditions: Supraventricular Tachycardia; Atrial Fibrillation (AF)

Treatments: Diagnostic Test: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings

Study type: Observational

Funder types: Other

Identifiers

NCT07148934

FIMEA/2025/002511-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For children in Study(SVT) group:

  1. received informed consent from both parents/guardians
  2. the child is treated in the Pediatric wards of Tyks Lighthouse hospital
  3. the child is between the age of 0-10 years
  4. the child has diagnosed or suspected SVT.

• For children in control group:

  1. received informed consent from both parents/guardians
  2. the child is treated in the Pediatric wards of Tyks Lighthouse hospital
  3. the child is between the age of 0-10 years
  4. child has not diagnosed with SVT

Exclusion criteria

• All participant groups:

  1. not reaching the inclusion criteria

Trial design

60 participants in 2 patient groups

Study( SVT) Group

Description:

Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse Hospital with diagnosed or suspected supraventricular tachycardia (SVT).

Treatment:

Diagnostic Test: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings

Control Group

Description:

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).

Treatment:

Diagnostic Test: Smartphone seismographic recording and Bed Based Ballistocardiographic recordings