Vital Signs MonitoringNCT07739823
Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient
An observational study of Vital Signs Monitoring and Physiologic Monitoring, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 12 years
- Conditions the study is for
- Vital Signs Monitoring, Physiologic Monitoring
- What is being tested?
- ANNE® Chest Sensor
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Vital Signs Monitoring, Physiologic Monitoring
- Being tested
- ANNE® Chest Sensor
- Keywords
- Wireless monitoring, Wearable sensors, Pediatric, Neonate, Infant, Intensive care, Physiologic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE® Chest SensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Hospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU). Receives: Device: ANNE® Chest Sensor | |
| Infants | Hospitalized infants aged 29 days to <2 years admitted to the NICU or PICU Receives: Device: ANNE® Chest Sensor | |
| Children | Hospitalized children aged 2 to <12 years admitted to the PICU Receives: Device: ANNE® Chest Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate Accuracy
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.
Measured: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
Heart Rate Accuracy
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.
Measured: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
Secondary outcomes (3)
Skin Tolerability
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.
Measured: Baseline (prior to device placement), immediately after device removal, and approximately 30 minutes after device removal.
Caregiver and Healthcare Provider Device Usability Perspective
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.
Measured: Immediately following completion of study participation.
Respiratory Rate Average Root Mean Squared Error (ARMS)
Average Root Mean Squared Error (ARMS) between respiratory rate measurements obtained from the ANNE® Chest sensor and the reference monitor within each age cohort.
Measured: Study monitoring period (4 to 8 hours per day over 2 consecutive days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Signs MonitoringStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme Sant'Anna, MD, PhD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739823
- Sponsor's protocol ID
- Wireless PICU
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Skin-Adherent Physiologic Sensor Validation in Pediatric Patients - Phase 1 Clinical Study
- ClinicalTrials.gov ID
- NCT07739823
- Acronym / sponsor ID
- Wireless PICU
- Conditions
- Vital Signs Monitoring, Physiologic Monitoring
- Keywords
- Wireless monitoring, Wearable sensors, Pediatric, Neonate, Infant, Intensive care, Physiologic monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Device: ANNE® Chest SensorHospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU). |
| Infants | – | Device: ANNE® Chest SensorHospitalized infants aged 29 days to <2 years admitted to the NICU or PICU |
| Children | – | Device: ANNE® Chest SensorHospitalized children aged 2 to <12 years admitted to the PICU |
Who may qualify
- Ages
- 0 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANNE® Chest SensorParticipants 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. | Device | Children, Infants, Neonates |
Primary outcome
Respiratory Rate Accuracy
Time frame: 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.
Heart Rate Accuracy
Time frame: 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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guilherme Sant'Anna, MD, PhD principal investigator
RI-MUHC
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs Monitoring and Physiologic Monitoring, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Maximov, BSc. (5149341934 ext. 78229, alyssa.maximov@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate Accuracy (time frame: Study monitoring period (4 to 8 hours per day over 2 consecutive days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.