Evaluating pupil response in patients suspected of brain death
Investigative Neurological Study With Pupillometric Evaluation os a Clinical Tool in Patients Declared Brain Dead (INSPECT) - a Prospective Quality Control Study
This study is testing if checking pupils by hand or using a special machine is better for figuring out if someone is brain dead.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Basel, Canton of Basel-City and 1 other locations) |
| Trial ID | NCT06279975 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the reliability of clinical pupil examinations in diagnosing brain death compared to automated pupillometric measurements. Conducted at the University Hospital Basel, the study involves two board-certified physicians performing standard clinical assessments alongside non-invasive pupillometry using the NeurOptics® NPi®-200 system. Data on demographics, clinical characteristics, and treatment will be collected anonymously to enhance the understanding of diagnostic accuracy in suspected brain death cases.
Who should consider this trial
Good fit: Ideal candidates are adults who are suspected of being brain dead and are undergoing diagnostic procedures in the intensive care unit.
Not a fit: Patients who are not suspected of brain death or are not in an intensive care setting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of brain death diagnoses, leading to better patient management and decision-making.
How similar studies have performed: While the approach of using automated pupillometry is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected diagnosis of brain death * Brain death diagnostic procedures planned * Treated at the intensive care unit at the University Hospital Basel (USB)
Where this trial is running
Basel, Canton of Basel-City and 1 other locations
- Intensive care unit at the University Hospital Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Raoul Sutter, Prof. — University Hospital, Basel, Switzerland
- Study coordinator: Raoul Sutter, Prof.
- Email: raoul.sutter@usb.ch
- Phone: +41 61 32 87928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.