RecruitingNCT05961176

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

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


Sponsor

The Hospital for Sick Children

Enrollment

100 participants

Start Date

Jan 17, 2024

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 1 MonthMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable smart textile (a sensor-embedded garment band) on children admitted to a cardiac critical care unit to see whether it can reliably monitor vital signs like heart rate and breathing rate. The goal is to evaluate this device as a potentially more comfortable and less intrusive alternative to standard hospital monitors. **You may be eligible if...** - You are between 1 month and 12 years old and admitted to SickKids Cardiac Critical Care Unit with an expected stay of more than 12 hours **You may NOT be eligible if...** - You have active wounds, chest tubes, or other devices that prevent the wearable garment from being placed correctly - You are on a heart-lung bypass machine (ECMO) - You have an implanted or temporary pacemaker or defibrillator - You are carrying a drug-resistant bacterial infection (MRSA) - You have imaging or procedures scheduled outside the unit within the next 12 hours - The garment does not fit your body size Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESkiin 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(1)

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

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NCT05961176


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