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| Name | Class |
|---|---|
| Myant Medical Corp. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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.***
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Infants and Children Admitted to the Cardiac Critical Care Unit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrien D'Alonzo | Contact | 416-813-7500 | 228624 | adrien.dalonzo@sickkids.ca |
| Aamir Jeewa, MD | Contact | aamir.jeewa@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Aamir Jeewa, MD | The Hospital for Sick Children | Principal Investigator |
| Michael-Alice Moga, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children (SickKids) | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18086928 | Background | 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. | |
| 20869642 | Background |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| 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. |
| 11685182 | 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. |
| 26675591 | 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. |
| 23279278 | 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. |
| 18811810 | 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. |
| 22308087 | 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. |
| 29724704 | 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. |