UnknownNot Applicable

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

Canada100 participantsStarted 2024-01-17

Plain-language 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).

Who can participate

Age range1 Month – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.

What they're measuring

Heart Rate

Timeframe: collection during the single study session of 2-12 hours.

Respiratory Rate

Timeframe: collection during the single study session of 2-12 hours.

Temperature

Timeframe: collection during the single study session of 2-12 hours.

Trial details

NCT IDNCT05961176

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-17

Contact for this trial

Adrien D'Alonzo

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

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range1 Month – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.