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Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Sponsor: KK Women's and Children's Hospital
Summary
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.
Key Details
Gender
FEMALE
Age Range
21 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2019-01-31
Completion Date
2025-12-31
Last Updated
2024-10-09
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
KK Women's and Children's Hospital
Singapore, Singapore