Validation of a device for monitoring vital signs in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Sainte Justin Hospital
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Azadeh Dastmalchi, PhD
• Email: azadeh.dastmalchi@vitaltracer.com
• Phone: +1(613)2761413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.