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

Recruiting

• Conditions: Heart Failure
• Interventions: Device: Skiin pediatric band and Skiin biometric pod

• Registration Number: NCT05961176
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2024-01-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-01-17
• Study Completion: 2026-01-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants and Children Admitted to the CCCU at SickKids	Skiin pediatric band and Skiin biometric pod	Inclusion Criteria: 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.

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	collection during the single study session of 2-12 hours.	The difference between respiratory rate measured from Skiin data and from standard of care device.
Heart Rate	collection during the single study session of 2-12 hours.	The difference between heart rate measured from Skiin data and from standard of care device.
Temperature	collection during the single study session of 2-12 hours.	The difference between temperature measured from Skiin data and from standard of care device.

Trial Locations

Locations (1)

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