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

April 17, 2024 updated by: Aamir Jeewa, The Hospital for Sick Children

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children (SickKids)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aamir Jeewa, MD
        • Principal Investigator:
          • Michael-Alice Moga, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants and Children Admitted to the Cardiac Critical Care Unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: collection during the single study session of 2-12 hours.
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
Time Frame: collection during the single study session of 2-12 hours.
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
Time Frame: collection during the single study session of 2-12 hours.
The difference between temperature measured from Skiin data and from standard of care device.
collection during the single study session of 2-12 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Myant Medical Corp.

Investigators

  • Principal Investigator: Aamir Jeewa, MD, The Hospital for Sick Children
  • Principal Investigator: Michael-Alice Moga, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Estimated)

January 17, 2025

Study Completion (Estimated)

January 17, 2026

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000079180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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