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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03754231
Other study ID # 2018/2223 (Paediatric)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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