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Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient

28 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

42

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Neonates
Hospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU).
Apparaat: 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.
Infants
Hospitalized infants aged 29 days to <2 years admitted to the NICU or PICU
Apparaat: 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.
Children
Hospitalized children aged 2 to <12 years admitted to the PICU
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Respiratory Rate Accuracy
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Skin Tolerability
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Onderzoekers

  • Hoofdonderzoeker: Guilherme Sant'Anna, MD, PhD, RI-MUHC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2026

Eerst geplaatst (Werkelijk)

31 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • Wireless PICU

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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