Monitoring vital signs in children using a connected patch
Validation of Continuous Monitoring of Vital Signs in Children With VTPatch Connected Device in the Pediatric Intensive Care Unit
This study tests a new patch that continuously monitors vital signs in kids in the PICU to see if it works as well as the standard monitoring equipment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | St. Justine's Hospital Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04627766 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the accuracy of a connected thoracic patch, known as the VT-Patch, for continuous monitoring of vital signs in pediatric patients who have been admitted to the pediatric intensive care unit (PICU). The device will monitor vital signs such as oxygen saturation, heart rate, respiratory rate, and temperature for a duration of 8 hours, with results compared to the standard Philips monitoring system. Additionally, the study will explore the device's capability to assess blood pressure, EKG, and movement capture, while also investigating the impact of skin color on the accuracy of these measurements.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who are admitted to the PICU and require monitoring for at least 24 hours.
Not a fit: Patients who have recently undergone cardiac or thoracic surgery or have contraindications such as thoracic skin lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a reliable method for early identification of pediatric patients at risk of readmission to the PICU.
How similar studies have performed: While similar monitoring devices have been developed for adults, this approach for children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU. * 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 is 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
- Principal investigator: Philippe Jouvet, MD, PhD — St. Justine's Hospital
- Study coordinator: Philippe Jouvet, MD, PhD
- Email: philippe.jouvet@umontreal.ca
- Phone: 514-345-4931
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.