Clinical trial NCT05961176: Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
Official title: Exploratory Study on Bio-Signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Wearable Electronic Device
Cardiovascular Disease
Critical Care
Pediatric
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Myant Medical Corp.
First posted: 2023-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and Children Admitted to the Cardiac Critical Care Unit

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.

Eligibility 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.\*\*\*

Primary outcomes:
measure: Heart Rate
timeFrame: collection during the single study session of 2-12 hours.
measure: Respiratory Rate
timeFrame: collection during the single study session of 2-12 hours.
measure: Temperature
timeFrame: collection during the single study session of 2-12 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Aamir Jeewa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Michael-Alice Moga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.