Orbital Artery Doppler Ultrasound in Brain Death

NCT06229782 | Completed

• 1 other identifier: 2017-15 /33
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum, the part of the central nervous system that remains inside the skull. The clinical diagnosis of brain death should be supported by ancillary tests that provide information about cerebral blood flow or electrical activity in the brain. Some of the ancillary tests that evaluate cerebral blood flow include transcranial Doppler ultrasonography (TDUS), computed tomography (CT) angiography (CTA), and catheter-based cerebral angiography. This study hypothesized that Orbital Doppler ultrasonography (ODUS) alone is more effective than TDUS in detecting intracranial blood flow in diagnosing brain death. To this end, the investigators examined the results of ODUS in patients diagnosed as brain dead who underwent CT angiography.

Conditions

Brain Death

Outcome Measures

Primary Outcomes (2)

• ODUS

  Orbital artery Doppler ultrasound (ODUS) ODUS measurements: T1; when brain death testing started; T2; 12 hours after the first measurement, T3; before CT angiography, T4; after CT angiography Peak systolic velocity (PSV) cm/s , end-diastolic velocity (EDV) cm/s measurement results. The absence of diastolic flow, reverse diastolic flow (oscillatory flow), and resistive index \>1 were considered brain death.

  30 minutes

• Resistive index (RI)

  The resistive index (RI) is a calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean Doppler frequency shifts during a defined cardiac cycle. Along with the pulsatility index (PI), it is typically used to assess the resistance in a pulsatile vascular system.resistive index \>1 were considered brain death. RI measurements: T1; when brain death testing started; T2; 12 hours after the first measurement, T3; before CT angiography, T4; after CT angiography . RI = (PSV - EDV) / PSV PSV = peak systolic velocity and EDV = end-diastolic velocity.

  30 minutes

Secondary Outcomes (3)

• Transcranial Doppler ultrasound (TDUS)

  30 minutes

• Cerebral blood flow (CTA)

  40 minutes

• Optic nerve diameter

  30 minutes

Study Arms (1)

ODUS

OTHER

Orbital Doppler ultrasonography (ODUS) Patients in whom brain death was suspected and the diagnostic procedure was initiated underwent ODUS .ODUS were performed during the apnoea test and the first neurological examination. At the second neurological examination at 12 hours, ODUS were repeated.

Diagnostic Test: Orbital Doppler ultrasonography; Diagnostic Test: Transcranial Doppler ultrasonography; Diagnostic Test: Computed Tomography Angiography

Interventions

Orbital Doppler ultrasonography DIAGNOSTIC_TEST

During measurement, Doppler settings were adjusted to detect low flow and the smallest available Doppler gate was used for all ODUS examinations. The imaging probe position for ODUS was used transversely and axially, and mean values were recorded. ODUS 10-18 MHz linear probe was used.

ODUS

Transcranial Doppler ultrasonography DIAGNOSTIC_TEST

During the measurement, Doppler settings were adjusted to detect low flow, and the minor available Doppler gate was used for all TDUS examinations. For TDUS, a temporal window was used approximately 1 cm above the midpoint of the line joining the lateral palpebral fissure and the external auditory meatus. Transcranial Doppler ultrasonography ( TDUS) 3-5 MHz convex array probe was used.

ODUS

Computed Tomography Angiography DIAGNOSTIC_TEST

Cranial Computed Tomography Angiography

ODUS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suspected brain death

You may not qualify if:

• eye surgery,
• uncontrolled diabetes mellitus,
• facial trauma,
• hypothermia,
• hypotension (systolic pressure \< 100 mm Hg)
• endocrine-metabolic coma

Sponsors & Collaborators

• Korgün Ökmen: lead

Study Sites (1)

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Death

Interventions

Ultrasonography, Doppler, Transcranial; Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography

Study Officials

• Korgün Ökmen

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 29, 2024
• Study Start: January 11, 2017
• Primary Completion: January 25, 2022
• Study Completion: June 13, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)