Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ANNE® Chest Sensor.
- Who it may be relevant to
- Registry conditions: Vital Signs Monitoring, Physiologic Monitoring. Basic parameters: 0 Days — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Wireless Skin-Adherent Physiologic Sensor Validation in Pediatric Patients - Phase 1 Clinical Study
Overview
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.
Interventions
- Device ANNE® Chest Sensor
Participants will wear the ANNE® Chest wireless skin-adherent physiologic sensor for continuous monitoring of heart rate, respiratory rate, electrocardiography (ECG), skin temperature, and body position during the study period. Measurements obtained from the investigational device will be compared with simultaneous standard-of-care bedside monitoring and capnography for validation purposes.
Primary outcome measures
- Respiratory Rate Accuracy [Time frame: Study monitoring period (4 to 8 hours per day over 2 consecutive days)]
- Heart Rate Accuracy [Time frame: Study monitoring period (4 to 8 hours per day over 2 consecutive days)]
Secondary outcome measures (3)
- Skin Tolerability [Time frame: Baseline (prior to device placement), immediately after device removal, and approximately 30 minutes after device removal.]
- Caregiver and Healthcare Provider Device Usability Perspective [Time frame: Immediately following completion of study participation.]
- Respiratory Rate Average Root Mean Squared Error (ARMS) [Time frame: Study monitoring period (4 to 8 hours per day over 2 consecutive days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07739823 · Wireless PICU