NCT05961176Recruiting
Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 18 Jul 2023
- Start date
- 17 Jan 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- The Hospital for Sick Children
- Diseases
- Heart failure
- NCT number
- NCT05961176
What you commit to
- Study type: Observational
- Planned participants: 100
- From 17 Jan 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 Methicillin-Resistant Staphylococcus aureus (MRSA) that represent an infection control risk.
Other
- 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 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.\*\*\*
Who the study is looking for
- 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.
Age in the registry: 1 month to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children (SickKids) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.