Validation of a Wireless Wearable Vital Signs Monitor in Pediatric Patient

July 28, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Neonates
Hospitalized neonates aged 0-28 days admitted to the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU).
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.
Infants
Hospitalized infants aged 29 days to <2 years admitted to the NICU or PICU
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.
Children
Hospitalized children aged 2 to <12 years admitted to the PICU
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin Tolerability
Time Frame: 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
Time Frame: 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)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guilherme Sant'Anna, MD, PhD, RI-MUHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Wireless PICU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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