Clinical trial NCT03262896: Neurophysiological Examination in Patients With Brain Death
Official title: Neurophysiological Study in Patients With Brain Death: A Single Center Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Keywords: Brain Death
Spinal Reflex
Electromyography
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the adult intensive care unit

Brief summary: This study examines muscle movements of elecromyography in adults with brain death. Half of the participants will have brain death, the other half will be healthy volunteers.

Detailed description: In some of the patients who have brain death diagnosis, some movements may be seen. Because of these movements, the doctors sometimes avoid to make brain death diagnosis. So making brain death diagnosis may delay. And in these patients, even if the brain death diagnosis made the family members refuse to donate the organs of the patients because they think their patients may survive when they see muscle movements with touch. These patients with brain death are lost in a short time, so some of the patients can not be used as donors. In this study, the investigators aim to raise awareness the movements in brain death patients can be seen, to study the movements neurophysiologically by EMG, whether EMG can be used as auxiliary method or not in brain death diagnosis and to raise organ donation numbers from cadavers. Investigators will examine the motor response and F response in the facial nerve, median nerve, and tibialis posterior nerve with electromyography neurophysiologically.

Eligibility criteria: Inclusion Criteria:

* Adult patients with definite diagnosis of brain death,
* Patients with permission from their parents,
* Patients without trauma of medullaspinalis and peripheral nerve injuries,
* Patients without previously known muscle disease (Myasthenia gravis, myopathy, etc.),
* Patients with previously unknown neurological disease (Amyotrophic Lateral Sclerosis, Multiple sclerosis, Guillain Barre syndrome, Poliomyelitis, etc.),
* Patients who have not previous systemic diseases (Connective Tissue Disease, Diabetes mellitus, Chronic renal failure, etc.).

Exclusion Criteria:

* Uncertain brain death,
* Patients without permission of family members,
* Younger than 18 years old and older than 72 years,
* Patients with medulla spinalis and peripheral nerve injuries,
* Patients with known muscle disease (Myasthenia gravis, myopathy, etc.),
* Patients with neurological disease (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Guillain Barre Syndrome, Poliomyelitis, etc.),
* Patients with previous systemic diseases (Connective Tissue Disease, Diabetes, Chronic Kidney Failure, etc.)

Primary outcomes:
measure: Axonal response
timeFrame: Within 72 hours from brain death diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University, School of Medicine
state: Tusba / Zeve Kampus
Study officials:
affiliation: Department of Anethesiology and Reanimation
name: Hilmi Demirkiran, MD
role: STUDY_DIRECTOR
affiliation: Department of Neurology
name: Aydin Cagac, MD
role: PRINCIPAL_INVESTIGATOR
References: