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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961176
• Other study ID #: 1000079180
• Status: Recruiting
• Start date: January 17, 2024
• Est. completion date: January 17, 2026

Study information

• Verified date: April 2024
• Source: The Hospital for Sick Children
• Contact: Adrien D'Alonzo
• Phone: 416-813-7500
• Email: adrien.dalonzo[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 17, 2026
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

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.***

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Myant Medical Corp.

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Andrews RE, Fenton MJ, Ridout DA, Burch M; British Congenital Cardiac Association. New-onset heart failure due to heart muscle disease in childhood: a prospective study in the United kingdom and Ireland. Circulation. 2008 Jan 1;117(1):79-84. doi: 10.1161/CIRCULATIONAHA.106.671735. Epub 2007 Dec 17. — View Citation

Jacob E, Duran J, Stinson J, Lewis MA, Zeltzer L. Remote monitoring of pain and symptoms using wireless technology in children and adolescents with sickle cell disease. J Am Assoc Nurse Pract. 2013 Jan;25(1):42-54. doi: 10.1111/j.1745-7599.2012.00754.x. Epub 2012 Jul 12. — View Citation

Kay JD, Colan SD, Graham TP Jr. Congestive heart failure in pediatric patients. Am Heart J. 2001 Nov;142(5):923-8. doi: 10.1067/mhj.2001.119423. No abstract available. — View Citation

Nandi D, Rossano JW. Epidemiology and cost of heart failure in children. Cardiol Young. 2015 Dec;25(8):1460-8. doi: 10.1017/S1047951115002280. — View Citation

Ware P, Ross HJ, Cafazzo JA, Laporte A, Seto E. Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol. JMIR Res Protoc. 2018 May 3;7(5):e121. doi: 10.2196/resprot.9911. — View Citation

Wilkinson JD, Landy DC, Colan SD, Towbin JA, Sleeper LA, Orav EJ, Cox GF, Canter CE, Hsu DT, Webber SA, Lipshultz SE. The pediatric cardiomyopathy registry and heart failure: key results from the first 15 years. Heart Fail Clin. 2010 Oct;6(4):401-13, vii. doi: 10.1016/j.hfc.2010.05.002. — View Citation

Zartner P, Handke R, Photiadis J, Brecher AM, Schneider MB. Performance of an autonomous telemonitoring system in children and young adults with congenital heart diseases. Pacing Clin Electrophysiol. 2008 Oct;31(10):1291-9. doi: 10.1111/j.1540-8159.2008.01180.x. — View Citation

Zartner PA, Toussaint-Goetz N, Photiadis J, Wiebe W, Schneider MB. Telemonitoring with implantable electronic devices in young patients with congenital heart diseases. Europace. 2012 Jul;14(7):1030-7. doi: 10.1093/europace/eur434. Epub 2012 Feb 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	The difference between heart rate measured from Skiin data and from standard of care device.	collection during the single study session of 2-12 hours.
Primary	Respiratory Rate	The difference between respiratory rate measured from Skiin data and from standard of care device.	collection during the single study session of 2-12 hours.
Primary	Temperature	The difference between temperature measured from Skiin data and from standard of care device.	collection during the single study session of 2-12 hours.