Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient
28 de julio de 2026 actualizado por: Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Wireless Skin-Adherent Physiologic Sensor Validation in Pediatric Patients - Phase 1 Clinical Study
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
42
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Alyssa Maximov, BSc.
- Número de teléfono: 78229 5149341934
- Correo electrónico: alyssa.maximov@muhc.mcgill.ca
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Hospitalized neonates, infants, and children (0 days to <12 years of age) admitted to the NICU or PICU at the Montreal Children's Hospital who require continuous physiologic monitoring and whose parent or legal guardian provides informed consent.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Neonates
Hospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU).
|
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.
|
|
Infants
Hospitalized infants aged 29 days to <2 years admitted to the NICU or PICU
|
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.
|
|
Children
Hospitalized children aged 2 to <12 years admitted to the PICU
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Respiratory Rate Accuracy
Periodo de tiempo: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
|
Agreement between respiratory rate measured by the ANNE® Chest wireless sensor and the reference standard capnography.
Accuracy will be evaluated using agreement analyses, with success defined as wearable-derived respiratory rate values within ±3 breaths per minute of the reference standard.
|
Study monitoring period (4 to 8 hours per day over 2 consecutive days)
|
|
Heart Rate Accuracy
Periodo de tiempo: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
|
Agreement between heart rate measured by the ANNE® Chest wireless sensor and the reference standard bedside monitor.
Accuracy will be evaluated using agreement analyses, with success defined as wearable-derived heart rate values within ±5 beats per minute of the reference monitor.
|
Study monitoring period (4 to 8 hours per day over 2 consecutive days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Skin Tolerability
Periodo de tiempo: Baseline (prior to device placement), immediately after device removal, and approximately 30 minutes after device removal.
|
Skin tolerability of the ANNE® Chest sensor, including the presence of erythema, irritation, or pressure marks following device use.
Skin integrity will be assess by comparing before and after photos of sites of placement of wearable sensors using the Berger & Bowman Scoring Scale.
|
Baseline (prior to device placement), immediately after device removal, and approximately 30 minutes after device removal.
|
|
Caregiver and Healthcare Provider Device Usability Perspective
Periodo de tiempo: Immediately following completion of study participation.
|
Caregiver and healthcare provider feedback regarding the usability and acceptability of the ANNE®.
Parent and clinician perceptions will be assessed using a custom study questionnaire containing Likert-scale, multiple-choice, and open-ended questions addressing usability, comfort, perceived safety, perceived accuracy, and overall acceptability of the wireless monitoring system.
|
Immediately following completion of study participation.
|
|
Respiratory Rate Average Root Mean Squared Error (ARMS)
Periodo de tiempo: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
|
Average Root Mean Squared Error (ARMS) between respiratory rate measurements obtained from the ANNE® Chest sensor and the reference monitor within each age cohort.
|
Study monitoring period (4 to 8 hours per day over 2 consecutive days)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Guilherme Sant'Anna, MD, PhD, RI-MUHC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
28 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
31 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Wireless PICU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
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