Orbital Artery Doppler Ultrasound in Brain Death

Brain Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06229782
• Other study ID #: 2017-15 /33
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: June 13, 2022

Study information

• Verified date: January 2024
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 13, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• suspected brain death

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Death
• Death

Intervention

Diagnostic Test:
• 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.
• 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.
• Computed Tomography Angiography
Cranial Computed Tomography Angiography

Locations

Country	Name	City	State
Turkey	University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Korgün Ökmen

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Transcranial Doppler ultrasound (TDUS)	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	30 minutes
Secondary	Cerebral blood flow (CTA)	Transcranial Computed Tomography Angiography	40 minutes
Secondary	Optic nerve diameter	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.	30 minutes