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

KK Women's and Children's Hospital

Status

Active, not recruiting

Conditions

Vital Sign

Respiratory Rate

Heart Rate

Treatments

Device: Vital sign monitoring

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03750318

2018/2223 (Women)

Details and patient eligibility

About

This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting 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.

Full 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. If any heart, respiration rate or skin temperature values move outside of pre-defined high and low limits (individually set for each patient) an alert is raised. ECG arrhythmia detection algorithms automatically record and send ECG data if the patient is suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation, Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW's Aingeal device within an adult in-patient setting 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.

Enrollment

39 patients

Sex

Female

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult female patients, aged 21 years or over
Patients admitted to post-operative gynaecological ward at KKH Women's and Children's Hospital, Singapore
Patients receiving opioid therapy via patient controlled analgesia (PCA)
Patients that are on electronic nursing charting
Patients that are on acute pain service monitoring

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 (Heart Rate detection algorithm has not been designed to reject foetal heart rate)