Brain DeathNCT06229782
Orbital Artery Doppler Ultrasound in Brain Death
A study testing Orbital Doppler ultrasonography, Transcranial Doppler ultrasonography and Computed Tomography Angiography in people with Brain Death, run by Korgün Ökmen at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Brain Death
- What is being tested?
- Orbital Doppler ultrasonography, Transcranial Doppler ultrasonography and Computed Tomography Angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2017to 13 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected brain death
Who cannot join
- eye surgery,
- uncontrolled diabetes mellitus,
- facial trauma,
- hypothermia,
- hypotension (systolic pressure < 100 mm Hg)
- endocrine-metabolic coma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Bursa
About this study
Official title: Orbital Artery Doppler Ultrasound as an Ancillary Test for Diagnosing Brain Death: a Prospective, Single Blind Comparative Study
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
- Being tested
- Orbital Doppler ultrasonography, Transcranial Doppler ultrasonography, Computed Tomography Angiography
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital Doppler ultrasonographyDiagnostic 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 ultrasonographyDiagnostic 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 AngiographyDiagnostic test
Cranial Computed Tomography Angiography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Orbital Doppler ultrasonography; Diagnostic Test: Transcranial Doppler ultrasonography; Diagnostic Test: Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Secondary outcomes (3)
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
Measured: 30 minutes
Cerebral blood flow (CTA)
Transcranial Computed Tomography Angiography
Measured: 40 minutes
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start11 Jan 2017
- Primary completion25 Jan 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korgün Ökmen
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229782
- Sponsor's protocol ID
- 2017-15 /33
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orbital Artery Doppler Ultrasound as an Ancillary Test for Diagnosing Brain Death: a Prospective, Single Blind Comparative Study
- ClinicalTrials.gov ID
- NCT06229782
- Acronym / sponsor ID
- 2017-15 /33
- Conditions
- Brain Death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Korgün ÖkmenOther government
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODUS | Other | Diagnostic Test: Orbital Doppler ultrasonography, Diagnostic Test: Transcranial Doppler ultrasonography, Diagnostic Test: Computed Tomography AngiographyOrbital 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- suspected brain death
Key exclusion criteria (6 listed)
- eye surgery,
- uncontrolled diabetes mellitus,
- facial trauma,
- hypothermia,
- hypotension (systolic pressure < 100 mm Hg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orbital Doppler ultrasonographyDuring 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. | Diagnostic test | ODUS |
| Transcranial Doppler ultrasonographyDuring 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. | Diagnostic test | ODUS |
| Computed Tomography AngiographyCranial Computed Tomography Angiography | Diagnostic test | ODUS |
Primary outcome
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.
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.
3 secondary outcomes
Transcranial Doppler ultrasound (TDUS)
Time frame: 30 minutes
Cerebral blood flow (CTA)
Time frame: 40 minutes
Optic nerve diameter
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korgün Ökmen principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orbital Doppler ultrasonography, Transcranial Doppler ultrasonography and Computed Tomography Angiography in people with Brain Death, run by Korgün Ökmen at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODUS (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.