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NCT03750318
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Conditions: Vital Sign, Heart Rate, Respiratory Rate
Sex: Female
Ages: 21 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 39
Sponsor: KK Women's and Children's Hospital
Location: KK Women's and Children's Hospital Singapore
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT03750318). StuddyBuddy aggregates publicly available trial information.