Vital Sign, Heart Rate, Respiratory Rate
Conditions
Keywords
Vital sign monitoring, Heart rate, Respiratory rate
Brief 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.
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.
Interventions
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
OTHERRespiratory 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
Sponsors
Renew Group
KK Women's and Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All patients recruited will be wearing the Aingeal device at a paediatric outpatient clinic setting.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate comparison | 15 minutes | Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate comparison | 15 minutes | Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach. |
Countries
Singapore
Outcome results
None listed