Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient (NCT07739823) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient
42 participantsStarted 2026-09-01
Plain-language summary
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the ANNE® Chest wireless wearable sensor for continuous monitoring of heart rate, respiratory rate, oxygen saturation, and skin temperature in hospitalized neonates, infants, and children (0 days to 12 years of age) in the neonatal and pediatric intensive care units (NICU and PICU). Measurements obtained from the wireless device will be compared with standard-of-care bedside monitoring and capnography. The study will also assess skin tolerability, signal reliability, and caregiver and healthcare provider perceptions of the device.
Who can participate
Age range
0 Days – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Neonates (0-28 days of life)
* Infants (29 days of life - 2 years, i.e., not turned 2 years old)
* Children (2 years old - 12 years old, i.e., not turned 12 years old)
Exclusion Criteria:
* Contraindication to application of skin sensors (e.g., rash, surgical site, skin breakdown, open wounds, burns, active dermatitis, etc.) at the application site.
* Severe hemodynamic instability requiring escalating interventions.
* Congenital airway abnormalities interfere with accurate capnography.
* Diagnosed neuromuscular disorders affecting respiratory mechanics.
* Known adhesive allergies.
* Inability to tolerate device placement due to behavioral issues.
* Participation in conflicting clinical trials.
* High-frequency oscillatory or mechanical ventilation.
* Active bronchiolitis with mask intolerance.
* Recent facial surgery preventing EtCO₂ nasal line placement.
* Behavioral conditions preventing adherence to device wearing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Respiratory Rate Accuracy
Timeframe: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
2
Heart Rate Accuracy
Timeframe: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
Trial details
NCT IDNCT07739823
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre