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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vital Sign, Heart Rate, Respiratory Rate

Intervention / Treatment
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* Device: Vital sign monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aingeal<br>All patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting. | Device: Vital sign monitoring<br>* Each patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Respiratory alarm rate per patient per day | De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived. | 3-4 days (upon admission till 1-3 days after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Cardiac alarm rate per patient per day | De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with an overall Alarm Rate per patient per day derived. | 3-4 days (upon admission till 1-3 days after surgery) | 
| False positive Respiratory alarm rate per patient per day | De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived. | 3-4 days (upon admission till 1-3 days after surgery) | 
| False positive Cardiac alarm rate per patient per day | De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived. | 3-4 days (upon admission till 1-3 days after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vital sign monitoring, Heart rate, Respiratory rate