Brain Death Diagnosis at an Academic Tertiary Medical Care Center

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.

Study Overview

• Status: Completed
• Conditions: Brain Death
• Intervention / Treatment: Other: Assessment of process required to diagnose brain death in adult patients

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Clinic for Intensive Care Medicine, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

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 hypothyreosis2.) 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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: diagnosis of brain death
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Death; Brain Death
• Other Study ID Numbers: 2019-00244; me19Sutter4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No