Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected diagnosis of brain death
Brain death diagnostic procedures planned
Treated at the intensive care unit at the University Hospital Basel (USB)
Disqualifiers
None
Trial population
The patient population is defined as all adult patients (i.e. ≥18 years of age) treated on the intensive care unit at the University Hospital Basel (USB) in whom the treating physicians suspect brain death and plan to perform brain death diagnostic procedures.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
non-invasive device-supported, automated pupillometry
Diagnostic testnon-invasive device-supported, automated pupillometry with a precise quantitative measurement of the pupils within the range of micrometers
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Reliability of clinical examination of pupils in patients with suspected brain death
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)
Time frame
baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation)Sponsors and contacts
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Source ClinicalTrials.gov