Orbital Artery Doppler Ultrasound in Brain Death

Not Applicable

Completed

• Conditions: Brain Death
• Interventions: Diagnostic Test: Orbital Doppler ultrasonography; Diagnostic Test: Transcranial Doppler ultrasonography; Diagnostic Test: Computed Tomography Angiography

• Registration Number: NCT06229782
• Lead Sponsor: Korgün Ökmen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Primary Completion: 2022-01-25
• Study Completion: 2022-06-13
• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-27
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• suspected brain death

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ODUS	Transcranial Doppler ultrasonography	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.
ODUS	Computed Tomography Angiography	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.
ODUS	Orbital Doppler ultrasonography	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.

Primary Outcome Measures

Name	Time	Method
ODUS	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.
Resistive index (RI)	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 Outcome Measures

Name	Time	Method
Transcranial Doppler ultrasound (TDUS)	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
Cerebral blood flow (CTA)	40 minutes	Transcranial Computed Tomography Angiography
Optic nerve diameter	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.

Trial Locations

Locations (1)

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,; 🇹🇷 Bursa, Turkey