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

Heart Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754231
• Other study ID #: 2018/2223 (Paediatric)
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Rate
• Respiratory Rate
• Vital Sign

Intervention

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
• 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

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Renew Group

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate comparison	Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach	15 minutes
Secondary	Respiratory rate comparison	Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.	15 minutes