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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive device-supported, automated pupillometry | Diagnostic Test | non-invasive device-supported, automated pupillometry with a precise quantitative measurement of the pupils within the range of micrometers |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline (2 hours before start of brain death evaluation) and 5 hours (2 hours after end of brain death evaluation) |
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Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raoul Sutter, Prof. | Contact | +41 61 32 87928 | raoul.sutter@usb.ch | |
| Pascale S Grzonka, MD | Contact | +41 61 32 84076 | PascaleSusanne.Grzonka@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Raoul Sutter, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care unit at the University Hospital Basel | Recruiting | Basel | Canton of Basel-City | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| University Hospital Basel | Recruiting | Basel | Switzerland |
|
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |