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

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.

Study Overview

• Status: Completed
• Conditions: Heart Rate; Respiratory Rate; Vital Sign
• Intervention / Treatment: Other: Heart rate monitoring; Other: Respiratory rate monitoring

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aingeal; 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; 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; Other: Respiratory rate monitoring; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Renew Group
• Investigators: Principal Investigator: Bao Bei Kelly Low, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 23, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Heart rate; Respiratory rate; Vital sign monitoring
• Other Study ID Numbers: 2018/2223 (Paediatric)

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: No