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Completed

NCT Number: NCT03754231

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.

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heart Rate Monitoring

Other

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

Other

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

Primary outcomes

  1. Heart rate comparison

    Time frame: 15 minutes

    Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach

Secondary outcomes

  1. Respiratory rate comparison

    Time frame: 15 minutes

    Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Renew Group

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2018
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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