Brain Death Diagnosis at an Academic Tertiary Medical Care Center

Study Overview
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Brief Summary
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The aim of this study is to assess and survey the quality of the process required to diagnose brain death in adult patients. This study of adult patients diagnosed brain dead or suspected of having brain death on the ICUs at the University Hospital Basel will be purely observational.

Official Title
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Brain Death Diagnosis at an Academic Tertiary Medical Care Center

Conditions
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Brain Death

Intervention / Treatment
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* Other: Assessment of process required to diagnose brain death in adult patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with suspected and/or diagnosed brain death adults 18 years and over

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Assessment of process required to diagnose brain death in adult patients|Assessment of process required to diagnose brain death in adult patients (demographics, clinical, laboratory, imaging, and treatment data). No questionnaires or study visits will be used.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosis | the local brain death protocol ( = measurement tool) requires 1.) exclusion of the following conditions: shock (mean arterial blood pressure > 60 mmHg, lactate < 4 mmol/l) hypothermia (temperature > 35°C) severe acidosis (pH > 7.3) hyperosmolarity (osmolarity < 320 mmol/l) severe electrolyte disorders (sodium > 125 mmol/l, phosphate > 0.3 mmol/l) hypoglycemia (glucose > 4 mmol/l) hyperammonemia (ammonia < 60 mumol/l) uremia (urea < 25 mmol/l) prolonged effects of medication (muscle relaxants, sedatives, recreational drugs) severe hypothyreosis 2.) clinical examination confirming: fixed pupils (dilated or mid-dilated bilaterally) absent vestibulo-ocular reflex absent corneal reflex bilaterally no reaction to painful stimulus bilaterally absence of cough and gag reflex absence of spontaneous breathing (apnea test) | single time point assessment at baseline (after suspected brain death) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of physicians involved | number of physicians involved in the diagnostic procedures | single time point assessment at baseline (after suspected brain death) | 
| frequency of ancillary tests performed | frequency of ancillary tests (i.e. transcranial doppler ultrasound, computed tomography, magnetic resonance tomography, digital substraction angiography, electroencephalogram, somatosensory evoked potentials) performed | single time point assessment at baseline (after suspected brain death) | 
| number of work-ups excluding suspected brain death | number of work-ups excluding suspected brain death | single time point assessment at baseline (after suspected brain death) | 
| number of diagnostic work-ups with insufficient performance and/or documentation | number of diagnostic work-ups with insufficient performance and/or documentation | single time point assessment at baseline (after suspected brain death) | 
| years of clinical experience of physicians involved | years of clinical experience of physicians involved in the diagnostic procedures | single time point assessment at baseline (after suspected brain death) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnosis of brain death