Monitoring heart function in children using smart textiles

Exploratory Study on Bio-Signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting

This study is testing a new smart textile device to see if it can safely and effectively monitor heart function in children staying in the hospital.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 1 Month to 12 Years
• Sex: All
• Sponsor: The Hospital for Sick Children (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05961176 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety, feasibility, usability, and validity of textile-enabled monitoring systems that capture physiological signals related to cardiopulmonary function in pediatric patients. It will compare data obtained from the Skiin Pediatric Band smart textile device to standard monitoring methods used in the SickKids Cardiac Critical Care Unit. The study will involve children aged 1 month to 12 years who are expected to stay in the unit for more than 12 hours, focusing on usability and clinician feedback regarding the textile devices.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to 12 years admitted to the SickKids Cardiac Critical Care Unit for more than 12 hours.

Not a fit: Patients with unstable conditions, active infections, or those requiring invasive devices that interfere with textile placement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring of heart function in pediatric patients, enhancing patient care and outcomes.

How similar studies have performed: While the use of wearable technology in healthcare is growing, this specific approach using smart textiles in pediatric critical care is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

1. Patients from 1 month of age to 12 years of age who are admitted to SickKids CCCU with expected stays in CCCU longer than 12 hours including those for medical management and post-surgical patients.

Exclusion Criteria:

1. Any existing condition, diagnosis or physiologic state, in the opinion of the principal investigator, Co-Investigators or most responsible physicians, in which presence of the study monitoring system may have negative effects on patient status or may impair care delivered by the treating team (e.g. hemodynamic instability, at risk for acute deterioration in condition).
2. Patients with active wounds or devices (such as a chest tube or invasive lines) in areas that prohibit placement of all configurations of textile device. \*
3. Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) that represent an infection control risk.
4. Patients cannulated to extracorporeal membrane oxygenation (ECMO).
5. Patients with imaging/procedures scheduled outside of the CCCU within the 12 hours following eligibility assessment. \*\*
6. Patients with an implanted cardioverter defibrillator (ICD)
7. Patients with a pacemaker, either implanted or temporary (temporary pacing wires not in use are allowed). \*\*\*
8. Patients whose chest/abdomen size is too large or small to fit the available sizes of the Skiin Pediatric Band.

Eligibility may be reassessed once an appropriate body location for the textile placement becomes available.\*

Eligibility may be reassessed after the patient returns to the CCCU.\*\*

Eligibility may be reassessed after the temporary pacemaker has been removed.\*\*\*

Where this trial is running

Toronto, Ontario

• The Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Aamir Jeewa, MD — The Hospital for Sick Children
• Study coordinator: Adrien D'Alonzo

Conditions: Heart Failure, Wearable Electronic Device, Cardiovascular Disease, Critical Care, Pediatric