An observational study in Brain Death, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by University Hospital, Basel, Switzerland · Observational
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 33 observational studies indexed under Brain Death.
Browse Brain Death studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of all adult (18 years or older) patients in whom brain death was suspected and/or diagnosed on the ICUs of the University Hospital Basel between January 1st 2008 and January 31st 2019.
Inclusion Criteria:
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.
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)
Time frame: single time point assessment at baseline (after suspected brain death)
number of physicians involved
number of physicians involved in the diagnostic procedures
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: single time point assessment at baseline (after suspected brain death)
Ran from Apr 2019 to primary completion in Dec 2020, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →