NCT05451875 Validation of Vital Signs Recording With VT-Patch Connected Devices in Children
| NCT ID | NCT05451875 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VitalTracer Ltd. |
| Condition | Vital Signs |
| Study Type | OBSERVATIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 48 participants in total. It began in 2025-02-03 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
: Patient readmission to PICU is a major point of concern for physicians because, although being a rare event, it has been strongly associated with more morbidity and death. Patient monitoring once they have left the PICU is drastically modified, and small connected devices could be an option to early identify patients at risk of PICU readmission. Such devices have been manufactured for the recording of vital signs in adults, but they do not exist for children. Besides, studies have recently shown that devices that use optical sensors may be less accurate in individuals with dark skin pigmentation since dark skin tones impose a limitation on optical biometric sensing. The wearable and medical device industry has not sufficiently addressed this issue yet. This is one of the main challenges that need to be addressed in this area to make sure the connected devices using this technology will work with all different skin colours including very dark skin.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05451875 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 18 Years, studying Vital Signs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05451875 currently recruiting?
Yes, NCT05451875 is actively recruiting participants. Contact the research team at azadeh.dastmalchi@vitaltracer.com for enrollment information.
Where is the NCT05451875 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05451875 clinical trial?
NCT05451875 is sponsored by VitalTracer Ltd.. The trial plans to enroll 48 participants.