Orbital Artery Doppler Ultrasound in Brain Death

NCT ID: NCT06229782

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2022-06-13

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Death

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ODUS

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.

Group Type OTHER

Orbital Doppler ultrasonography

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Cranial Computed Tomography Angiography

Interventions

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Orbital Doppler ultrasonography

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.

Intervention Type DIAGNOSTIC_TEST

Transcranial Doppler ultrasonography

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.

Intervention Type DIAGNOSTIC_TEST

Computed Tomography Angiography

Cranial Computed Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* suspected brain death

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korgün Ökmen

OTHER_GOV

Sponsor Role lead

Responsible Party

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Korgün Ökmen

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Korgün Ökmen

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

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

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017-15 /33

Identifier Type: -

Identifier Source: org_study_id

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