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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Rate; Respiratory Rate; Vital Sign
• Intervention / Treatment: Device: Vital sign monitoring

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aingeal; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Renew Group
• Investigators: Study Director: Ban Leong Sng, FANZCA, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): May 5, 2019
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Heart rate; Respiratory rate; Vital sign monitoring
• Other Study ID Numbers: 2018/2223 (Women)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No