Adults, Brain Death
Conditions
Keywords
Pupillometry, Brain Death, Diagnosis
Brief 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.
Detailed description
This prospective quality control study will evaluate the reliability of the clinical exam regarding pupils' reaction to light (as performed by two board certified physicians in Neurology and/or Intensive Care Medicine) as recommended by the SAMW guidelines for brain death diagnosis (SAMW-guidelines) when compared to the results of a noninvasive automated and highly-precise pupillometry in adult patients with clinically suspected brain death. Automated pupillometric measurements will be performed by the PI (RS), or the co-investigator (Dr. Pascale Grzonka) using the NeurOptics® NPi®-200 pupillometer system immediately before and after the standardized diagnostic workup for suspected brain death. In addition, demographics, clinical characteristics , treatment and laboratory data from the patients examined will be anonymously collected.
Interventions
DIAGNOSTIC_TESTnon-invasive device-supported, automated pupillometry
non-invasive device-supported, automated pupillometry with a precise quantitative measurement of the pupils within the range of micrometers
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected diagnosis of brain death * Brain death diagnostic procedures planned * Treated at the intensive care unit at the University Hospital Basel (USB)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliability of clinical examination of pupils in patients with suspected brain death | baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation) | Determination of 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 noninvasive, automated, and highly precise pupillometric examination (measurement of the discordance between automated analyses of pupillary light reflex by a hand-held pupillometer and visual examination without pupillometer support in percentage) |
Countries
Switzerland
Contacts
CONTACTRaoul Sutter, Prof.
CONTACTPascale S Grzonka, MD
PRINCIPAL_INVESTIGATORRaoul Sutter, Prof.
University Hospital, Basel, Switzerland
Outcome results
None listed