Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

Study Overview
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Brief Summary
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This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital (KKH), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Detailed Description
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RENEW's Surveillance Monitoring system is made up of two main components: a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population in KK Women's and Children's Hospital (KKH), the main tertiary women and children hospital in Singapore. In the paediatric population, assessment of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from single lead ECG and at deriving respiratory rate when compared against a commonly used vital signs monitor. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.

Official Title
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Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital

Conditions
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Vital Sign, Heart Rate, Respiratory Rate

Intervention / Treatment
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* Other: Heart rate monitoring
* Other: Respiratory rate monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female paediatric patients, aged between 3 and 17 years Patients attending outpatient care at KK Women's and Children's Hospital, Singapore Exclusion Criteria: Patients with active, implantable devices (such as a pacemaker or ICD) Patients with any skin condition or injury affecting the electrode placement site Patients that are pregnant Those patients who, in the opinion of the clinic staff, are not suitable to participate.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All patients recruited will be wearing the Aingeal device at a paediatric outpatient clinic setting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aingeal<br>All recruited patients will wear the Aingeal device as a form of heart rate monitoring and respiratory rate monitoring in a paediatric outpatient clinic setting. | Other: Heart rate monitoring<br>* The heart rate of recruited patients will be monitored for 15 minutes over 2 phases: i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing<br>Other: Respiratory rate monitoring<br>* The heart rate of recruited patients will be monitored for 15 minutes over 2 phases: i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate comparison | Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate comparison | Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vital sign monitoring, Heart rate, Respiratory rate