Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study (NCT06279975) | Clinical Trial Compass
RecruitingNot Applicable
Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study
Switzerland50 participantsStarted 2023-12-18
Plain-language summary
The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Suspected diagnosis of brain death
* Brain death diagnostic procedures planned
* Treated at the intensive care unit at the University Hospital Basel (USB)
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.
1This study is about evaluating pupils in patients who are suspected to be brain dead — can you explain what that assessment process currently looks like, and how this study might change or improve it?
2Since this trial is focused on quality control of the brain death examination rather than testing a new treatment, what does participation actually involve for the patient or their family, and are there any additional procedures beyond what would normally be done?
3The study is measuring the reliability of pupil checks during brain death evaluation — does that mean there's currently some uncertainty in how accurate those checks are, and what does that mean for how decisions are being made right now?
4Given that this is a prospective observational study and not a treatment trial, how might the findings here eventually affect the standards used to confirm brain death in hospitals more broadly?
5Are there any privacy or consent considerations our family should be aware of, given that this study involves patients who may not be able to give consent themselves?
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
Reliability of clinical examination of pupils in patients with suspected brain death
Timeframe: baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)