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

NCT05961176 | Recruiting DMC

• 1 other identifier: 1000079180
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Keywords

Wearable Electronic Device; Cardiovascular Disease; Critical Care; Pediatric

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

Infants and Children Admitted to the CCCU at SickKids

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.

Device: Skiin pediatric band and Skiin biometric pod

Interventions

Skiin pediatric band and Skiin biometric pod DEVICE

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.

Infants and Children Admitted to the CCCU at SickKids

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants and Children Admitted to the Cardiac Critical Care Unit

You may qualify if:

• \. 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.

You may not qualify if:

• 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).
• 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. \*
• Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) that represent an infection control risk.
• Patients cannulated to extracorporeal membrane oxygenation (ECMO).
• Patients with imaging/procedures scheduled outside of the CCCU within the 12 hours following eligibility assessment. \*\*
• Patients with an implanted cardioverter defibrillator (ICD)
• Patients with a pacemaker, either implanted or temporary (temporary pacing wires not in use are allowed). \*\*\*
• 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.\*\*\*

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Myant Medical Corp.: collaborator

Study Sites (1)

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related 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.

  PMID: 18086928 BACKGROUND

• 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.

  PMID: 20869642 BACKGROUND

• 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.

  PMID: 11685182 BACKGROUND

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

  PMID: 26675591 BACKGROUND

• 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.

  PMID: 23279278 BACKGROUND

• 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.

  PMID: 18811810 BACKGROUND

• 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.

  PMID: 22308087 BACKGROUND

• 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.

  PMID: 29724704 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Aamir Jeewa, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Michael-Alice Moga, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien D'Alonzo

CONTACT

416-813-7500; adrien.dalonzo@sickkids.ca

Aamir Jeewa, MD

CONTACT

aamir.jeewa@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: January 17, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)