Monitoring heart function in children using smart textiles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Aamir Jeewa, MD — The Hospital for Sick Children
• Study coordinator: Diana Balmer-Minnes
• Email: diana.balmer-minnes@sickkids.ca
• Phone: 416-813-7500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.