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NCT Number: NCT06229782

Orbital Artery Doppler Ultrasound in Brain Death

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bursa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • suspected brain death

Exclusion criteria

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

Treatment and study plan

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.

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.

Computed Tomography Angiography

Diagnostic Test

Cranial Computed Tomography Angiography

Primary outcomes

  1. ODUS

    Time frame: 30 minutes

    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.

  2. Resistive index (RI)

    Time frame: 30 minutes

    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.

Secondary outcomes

  1. Transcranial Doppler ultrasound (TDUS)

    Time frame: 30 minutes

    Transcranial Doppler ultrasound (TDUS) ultrasonography involves the use of a low-frequency (≤2 MHz) transducer, placed on the scalp, to insonate the basal cerebral arteries through relatively thin bone windows and to measure the cerebral blood flow velocity (CBFV) normal flow: mean = 55cm/sec. mild: > 120cm/sec. moderate: > 160cm/sec. s

  2. Cerebral blood flow (CTA)

    Time frame: 40 minutes

    Transcranial Computed Tomography Angiography

  3. Optic nerve diameter

    Time frame: 30 minutes

    Optic nerve diameter (mm) Orbital artery Doppler was performed simultaneously with ultrasound. The imaging probe position was used transversely and axially and mean values were recorded.

Sponsors and collaborators

Lead sponsor

Korgün Ökmen

Other Gov

Registry information

Official study title

Orbital Artery Doppler Ultrasound as an Ancillary Test for Diagnosing Brain Death: a Prospective, Single Blind Comparative Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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