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

KK Women's and Children's Hospital

Status: Completed

Conditions: Vital Sign; Respiratory Rate; Heart Rate

Treatments: Other: Heart rate monitoring; Other: Respiratory rate monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03754231

2018/2223 (Paediatric)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Aingeal

Experimental group

Description:

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.

Treatment:

Other: Respiratory rate monitoring

Other: Heart rate monitoring