Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital (NCT03750318) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
Singapore39 participantsStarted 2019-01-31
Plain-language 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.
Who can participate
Age range
21 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Respiratory alarm rate per patient per day
Timeframe: 3-4 days (upon admission till 1-3 days after surgery)