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

Heart Failure

The primary research objective is to determine the safety, feasibility, usability and validity of textile-enabled monitoring systems designed to capture physiologic variables, or "biological signals," related to cardiopulmonary function in children through comparison to hospital-based, standard-of-care monitoring in the Sickkids Cardiac Critical Care Unit (CCCU).

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    1 to 12

Participation 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.\*\*\*

Study Location

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

Contact Study Team

Backup Contact

Diana Balmer-Minnes

[email protected]
416-813-7500
Primary Contact

Adrien D'Alonzo

[email protected]
416-813-7500
Study Sponsored By
The Hospital for Sick Children
Participants Required
More Information
Study ID: NCT05961176