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Brain Death Diagnosis at an Academic Tertiary Medical Care Center

Brain Death Diagnosis at an Academic Tertiary Medical Care Center

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03984981
Enrollment
100
Registered
2019-06-13
Start date
2019-04-03
Completion date
2020-12-31
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

diagnosis of brain death

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.

Interventions

OTHERAssessment 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.

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with suspected and/or diagnosed brain death * adults 18 years and over

Design outcomes

Primary

MeasureTime frameDescription
adherence to the local brain death protocol ( = measurement tool) for the process of brain death diagnosissingle 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

MeasureTime frameDescription
number of physicians involvedsingle time point assessment at baseline (after suspected brain death)number of physicians involved in the diagnostic procedures
frequency of ancillary tests performedsingle 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 deathsingle 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 documentationsingle 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 involvedsingle time point assessment at baseline (after suspected brain death)years of clinical experience of physicians involved in the diagnostic procedures

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026