Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT05961176

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Interventions

Skiin pediatric band and Skiin biometric pod

Study Details

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

Study ID

NCT05961176

Start date

Jan 17, 2024

Status verified date

Apr, 2024

Completion date

Jan 17, 2026

Anticipated

Primary completion date

Jan 17, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

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:

1. 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).
2. 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. \*
3. Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) that represent an infection control risk.
4. Patients cannulated to extracorporeal membrane oxygenation (ECMO).
5. Patients with imaging/procedures scheduled outside of the CCCU within the 12 hours following eligibility assessment. \*\*
6. Patients with an implanted cardioverter defibrillator (ICD)
7. Patients with a pacemaker, either implanted or temporary (temporary pacing wires not in use are allowed). \*\*\*
8. 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.\*\*\*

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Skiin 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.

Primary outcome measure

  • Heart Rate [ Time Frame: collection during the single study session of 2-12 hours. ]
  • Respiratory Rate [ Time Frame: collection during the single study session of 2-12 hours. ]
  • Temperature [ Time Frame: collection during the single study session of 2-12 hours. ]

Central Contacts and Locations

Central contacts

Locations

The Hospital for Sick Children (SickKids)

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Principal Investigator:

Aamir Jeewa, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Keywords

  • Wearable Electronic Device
  • Cardiovascular Disease
  • Critical Care
  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2024-04-18.