NCT05961176

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Month – 12 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This single-arm, non-randomized study is a usability, technology feasibility and data correlation study which will employ a convenience sampling method. The study will compare the quality of data obtained by the Myant Inc Skiin Pediatric Band smart textile device to the gold-standard data generated by the clinical devices in the CCCU at SickKids. 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 CCCU. The secondary objectives are as follows; (1) To design textiles for infants and children that allow safe, developmentally appropriate care, (2) To investigate the optimum placement of biosensors to measure physiologic parameters such as heart and respiratory rate within the textile-based approach, (3) To validate the textile-based approach, including the integrated sensors, through comparison to physiologic data gathered as part of routine patient care through traditional comparative analysis, (4) To investigate usability of the textiles, including placement, removal, and effects on patient care activities, and (5) To gather clinician feedback on the textile use and design.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Skiin pediatric band and Skiin biometric pod	Infants that meet the inclusion criteria will be equipped with a Skiin pediatric band appropriate for their chest size. Heart rate, respiratory rate, temperature, and electrocardiogram will be monitored from 2 to 12 hours through the Skiin pediatric band and a standard of care device (Phillips Intellivue MX750) commonly used in the CCCU at SickKids.

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-01-17
• Completion: 2026-01-17
• First posted: 2023-07-27
• Last updated: 2024-04-18

Locations

1 site across 1 country: Canada