Brain Death Diagnosis at an Academic Tertiary Medical Care Center
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosis [single time point assessment at baseline (after suspected brain death)]
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)
Secondary Outcome Measures
- number of physicians involved [single time point assessment at baseline (after suspected brain death)]
number of physicians involved in the diagnostic procedures
- frequency of ancillary tests performed [single time point assessment at baseline (after suspected brain death)]
frequency of ancillary tests (i.e. transcranial doppler ultrasound, computed tomography, magnetic resonance tomography, digital substraction angiography, electroencephalogram, somatosensory evoked potentials) performed
- number of work-ups excluding suspected brain death [single time point assessment at baseline (after suspected brain death)]
number of work-ups excluding suspected brain death
- number of diagnostic work-ups with insufficient performance and/or documentation [single time point assessment at baseline (after suspected brain death)]
number of diagnostic work-ups with insufficient performance and/or documentation
- years of clinical experience of physicians involved [single time point assessment at baseline (after suspected brain death)]
years of clinical experience of physicians involved in the diagnostic procedures
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients with suspected and/or diagnosed brain death
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adults 18 years and over
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic for Intensive Care Medicine, University Hospital Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-00244; me19Sutter4