Validation of a device for monitoring vital signs in children
Validation of Vital Signs Recording With VT-Patch® Connected Devices in Children
This study is testing a new device called the VT-Patch® to see if it accurately measures vital signs like heart rate and temperature in children with different skin colors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | VitalTracer Ltd. Industry-sponsored |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05451875 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the accuracy of the VT-Patch® device in measuring vital signs such as oxygen saturation, heart rate, respiratory rate, and temperature in children of varying skin colors. The study will be conducted in two phases, starting with a run-in phase involving four children to assess protocol feasibility, followed by a main validation phase with 12 children per age group. The device's readings will be compared to standard monitoring systems over an 8-hour period to ensure reliability and accuracy. The study also addresses the challenge of optical sensor accuracy in individuals with darker skin tones.
Who should consider this trial
Good fit: Ideal candidates for this study are children who are being monitored in the PICU for at least 24 hours.
Not a fit: Patients who have recently undergone cardiac or thoracic surgery or have contraindications to the VT-Patch® will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of children's vital signs, potentially reducing the risk of readmission to the Pediatric Intensive Care Unit (PICU).
How similar studies have performed: While there have been studies on similar devices for adults, this specific approach for children, particularly addressing skin color disparities, is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PICU monitoring for the next 24 hours Exclusion Criteria: * Recent cardiac or thoracic surgery * Thoracic skin lesion that contraindicates the VT patch * No parental consent * Intermittent presence of one study observer in the patient room considered inappropriate by the physician or the nurse in charge because of the child's medical condition
Where this trial is running
Montreal, Quebec
- CHU Sainte Justin Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Azadeh Dastmalchi, PhD
- Email: azadeh.dastmalchi@vitaltracer.com
- Phone: +1(613)2761413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.