Cardiac Arrest (CA)NCT07918391
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
An observational study of Cardiac Arrest (CA) and Carotid Doppler, run by Inonu University.
Trial summary
Out-of-hospital cardiac arrest (OHCA) is one of the most critical conditions in emergency medicine, causing high mortality and severe neurological sequelae due to the sudden cessation of circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Carotid Doppler
- What is being tested?
- Carotid Doppler Ultrasonography, Transcranial Doppler, Optic Nerve Sheath Diameter Measurement, and Cerebral Oximetry
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the intensive care unit after out-of-hospital cardiac arrest.
Who may be able to join
- Age 18 years or older Admitted to the ICU after out-of-hospital cardiac arrest Hemodynamically stable PaCO2 35-45 mmHg
Who cannot join
- Age under 18 years In-hospital cardiac arrest Anatomical abnormalities or skin lesions preventing carotid or cerebral ultrasonographic measurement Hemodynamic instability
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EFFECTS OF CAROTID DOPPLER ULTRASONOGRAPHY AND CEREBRAL OXIMETRY ON SURVIVAL AND NEUROLOGICAL OUTCOMES IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT FOLLOWING OUT OF HOSPITAL CARDIAC ARREST
Out-of-hospital cardiac arrest (OHCA) is one of the most critical conditions in emergency medicine, causing high mortality and severe neurological sequelae due to the sudden cessation of circulation. Among the hundreds of thousands of patients affected worldwide, a significant proportion die or face permanent neurological impairment from hypoxic-ischemic brain injury, even after return of spontaneous circulation (ROSC). Therefore, early and reliable assessment of brain injury after cardiac arrest is of great importance both for clinical decision-making and for the effective use of treatment resources.
Various methods are currently used to predict neurological prognosis after cardiac arrest, including computed tomography, magnetic resonance imaging, electroencephalography, and biochemical markers (NSE, S100B). However, some of these methods are expensive, have limited availability, or can be difficult to apply in the management of critically ill patients. In this context, bedside ultrasonography and cerebral oximetry, being applicable at the bedside, non-invasive, and repeatable, stand out as valuable alternative tools for clinicians.
Read more
Carotid Doppler ultrasonography provides indirect information about cerebral perfusion by measuring parameters such as peak systolic velocity (PSV), end-diastolic velocity (EDV), mean velocity (MV), pulsatility index (PI), and resistive index (RI) in the common carotid arteries. High PI and RI values indicate increased intracranial pressure or impaired cerebral vasomotor response, and these findings may be associated with poor neurological outcome. Similarly, transcranial Doppler (TCD) performed via the transtemporal approach reflects the integrity of cerebral autoregulation and cerebral perfusion pressure through middle cerebral artery (MCA) flow velocities and pulsatility values.
Optic nerve sheath diameter (ONSD) measurement is an increasingly widespread ultrasound application serving as a non-invasive indicator of elevated intracranial pressure. The optic nerve sheath is known to widen in the presence of cerebral edema, and this finding is thought to be associated with neurological deterioration.
Non-invasive cerebral oximetry (rSO2) continuously monitors frontal cerebral oxygen saturation, allowing early detection of periods of cerebral hypoxia. Inadequate cerebral oxygenation after cardiac arrest has been shown to be directly associated with poor prognosis. However, comprehensive studies interpreting this parameter together with Doppler ultrasonography findings are still lacking.
The primary aim of this study is to prospectively investigate the predictive value of carotid Doppler (internal, external, and common carotid arteries), TCD-MCA, and ONSD measurements, together with non-invasive cerebral oximetry values, for 60-day mortality and neurological outcome (Cerebral Performance Category, CPC scale) in patients admitted to the ICU due to OHCA. Secondary aims include examining the correlations between these parameters and determining the earliest and most reliable prognostic cut-off values.
The results of this study are expected to contribute to early neurological prognostication and patient management in ICU patients after OHCA
- Conditions
- Cardiac Arrest (CA), Carotid Doppler
- Being tested
- Carotid Doppler Ultrasonography, Transcranial Doppler, Optic Nerve Sheath Diameter Measurement, and Cerebral Oximetry
- Keywords
- transcranial doppler ultrasonography, carotid doppler, pulsatility index, resistive index, cerebral hemodynamics, cerebral oximetry
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Doppler Ultrasonography, Transcranial Doppler, Optic Nerve Sheath Diameter Measurement, and Cerebral OximetryDiagnostic test
Non-invasive bedside measurements performed alongside routine ICU care. Carotid Doppler ultrasonography (internal, external, and common carotid arteries) records peak systolic velocity, end-diastolic velocity, mean velocity, pulsatility index, and resistive index. Transcranial Doppler of the middle cerebral artery and optic nerve sheath diameter are measured within the first 24 hours, at 72 hours, and on days 5-7 after ICU admission. Cerebral oxygen saturation (rSO2) is monitored continuously with near-infrared spectroscopy during the first 72 hours, with the lowest and mean values recorded every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Adult OHCA Patients Admitted to the ICU Group | Adult patients (≥18 years) admitted to the intensive care unit after out-of-hospital cardiac arrest who are hemodynamically stable with PaCO2 35-45 mmHg. Carotid Doppler, transcranial Doppler (MCA), and optic nerve sheath diameter are measured within the first 24 hours, at 72 hours, and on days 5-7. Cerebral oximetry (rSO2) is monitored continuously during the first 72 hours. Receives: Diagnostic Test: Carotid Doppler Ultrasonography, Transcranial Doppler, Optic Nerve Sheath Diameter Measurement, and Cerebral Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Carotid Doppler Indices and Neurological Outcome (CPC) After Out-of-Hospital Cardiac Arrest
Pulsatility index and resistive index of the internal, external, and common carotid arteries, measured within the first 24 hours, at 72 hours, and on days 5-7 after ICU admission, will be analyzed for their association with neurological outcome assessed by the Cerebral Performance Category (CPC) scale.
Measured: 60 days after ICU admission
Secondary outcomes (3)
Association Between Carotid Doppler Indices and Mortality After Out-of-Hospital Cardiac Arrest
Peak systolic velocity, end-diastolic velocity, mean velocity, pulsatility index, and resistive index of the internal, external, and common carotid arteries, measured within the first 24 hours, at 72 hours, and on days 5-7 after ICU admission, will be analyzed for their association with all-cause mortality.
Measured: 60 days after ICU admission
Association Between Optic Nerve Sheath Diameter and Neurological Outcome and Mortality
Optic nerve sheath diameter measured by ultrasonography within the first 24 hours, at 72 hours, and on days 5-7 will be analyzed for its association with CPC-based neurological outcome and mortality.
Measured: 60 days after ICU admission
Association Between Cerebral Oximetry (rSO2) and Neurological Outcome and Mortality
Lowest and mean regional cerebral oxygen saturation (rSO2) values recorded every 6 hours during the first 72 hours of ICU stay, measured by near-infrared spectroscopy, will be analyzed for their association with CPC-based neurological outcome and mortality.
Measured: First 72 hours of ICU stay for measurement; outcomes assessed at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918391
- Sponsor's protocol ID
- 10369
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because patient data are anonymously coded and will not be shared with third parties, in line with the ethics committee approval. Aggregate results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF CAROTID DOPPLER ULTRASONOGRAPHY AND CEREBRAL OXIMETRY ON SURVIVAL AND NEUROLOGICAL OUTCOMES IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT FOLLOWING OUT OF HOSPITAL CARDIAC ARREST
- ClinicalTrials.gov ID
- NCT07918391
- Acronym / sponsor ID
- 10369
- Conditions
- Cardiac Arrest (CA), Carotid Doppler
- Keywords
- transcranial doppler ultrasonography, carotid doppler, pulsatility index, resistive index, cerebral hemodynamics, cerebral oximetry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
Out-of-hospital cardiac arrest (OHCA) is one of the most critical conditions in emergency medicine, causing high mortality and severe neurological sequelae due to the sudden cessation of circulation. Among the hundreds of thousands of patients affected worldwide, a significant proportion die or face permanent neurological impairment from hypoxic-ischemic brain injury, even after return of spontaneous circulation (ROSC). Therefore, early and reliable assessment of brain injury after cardiac arrest is of great importance both for clinical decision-making and for the effective use of treatment resources.
Various methods are currently used to predict neurological prognosis after cardiac arrest, including computed tomography, magnetic resonance imaging, electroencephalography, and biochemical markers (NSE, S100B). However, some of these methods are expensive, have limited availability, or can be difficult to apply in the management of critically ill patients. In this context, bedside ultrasonography and cerebral oximetry, being applicable at the bedside, non-invasive, and repeatable, stand out as valuable alternative tools for clinicians.
Carotid Doppler ultrasonography provides indirect information about cerebral perfusion by measuring parameters such as peak systolic velocity (PSV), end-diastolic velocity (EDV), mean velocity (MV), pulsatility index (PI), and resistive index (RI) in the common carotid arteries. High PI and RI values indicate increased intracranial pressure or impaired cerebral vasomotor response, and these findings may be associated with poor neurological outcome. Similarly, transcranial Doppler (TCD) performed via the transtemporal approach reflects the integrity of cerebral autoregulation and cerebral perfusion pressure through middle cerebral artery (MCA) flow velocities and pulsatility values.
Optic nerve sheath diameter (ONSD) measurement is an increasingly widespread ultrasound application serving as a non-invasive indicator of elevated intracranial pressure. The optic nerve sheath is known to widen in the presence of cerebral edema, and this finding is thought to be associated with neurological deterioration.
Non-invasive cerebral oximetry (rSO2) continuously monitors frontal cerebral oxygen saturation, allowing early detection of periods of cerebral hypoxia. Inadequate cerebral oxygenation after cardiac arrest has been shown to be directly associated with poor prognosis. However, comprehensive studies interpreting this parameter together with Doppler ultrasonography findings are still lacking.
The primary aim of this study is to prospectively investigate the predictive value of carotid Doppler (internal, external, and common carotid arteries), TCD-MCA, and ONSD measurements, together with non-invasive cerebral oximetry values, for 60-day mortality and neurological outcome (Cerebral Performance Category, CPC scale) in patients admitted to the ICU due to OHCA. Secondary aims include examining the correlations between these parameters and determining the earliest and most reliable prognostic cut-off values.
The results of this study are expected to contribute to early neurological prognostication and patient management in ICU patients after OHCA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult OHCA Patients Admitted to the ICU Group | – | Diagnostic Test: Carotid Doppler Ultrasonography, Transcranial Doppler, Optic Nerve Sheath Diameter Measurement, and Cerebral OximetryAdult patients (≥18 years) admitted to the intensive care unit after out-of-hospital cardiac arrest who are hemodynamically stable with PaCO2 35-45 mmHg. Carotid Doppler, transcranial Doppler (MCA), and optic nerve sheath diameter are measured within the first 24 hours, at 72 hours, and on days 5-7. Cerebral oximetry (rSO2) is monitored continuously during the first 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit after out-of-hospital cardiac arrest.
Key inclusion criteria (1 listed)
- Age 18 years or older Admitted to the ICU after out-of-hospital cardiac arrest Hemodynamically stable PaCO2 35-45 mmHg
Key exclusion criteria (1 listed)
- Age under 18 years In-hospital cardiac arrest Anatomical abnormalities or skin lesions preventing carotid or cerebral ultrasonographic measurement Hemodynamic instability
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 |
|---|---|---|
| Carotid Doppler Ultrasonography, Transcranial Doppler, Optic Nerve Sheath Diameter Measurement, and Cerebral OximetryNon-invasive bedside measurements performed alongside routine ICU care. Carotid Doppler ultrasonography (internal, external, and common carotid arteries) records peak systolic velocity, end-diastolic velocity, mean velocity, pulsatility index, and resistive index. Transcranial Doppler of the middle cerebral artery and optic nerve sheath diameter are measured within the first 24 hours, at 72 hours, and on days 5-7 after ICU admission. Cerebral oxygen saturation (rSO2) is monitored continuously with near-infrared spectroscopy during the first 72 hours, with the lowest and mean values recorded every 6 hours. | Diagnostic test | Adult OHCA Patients Admitted to the ICU Group |
Primary outcome
Association Between Carotid Doppler Indices and Neurological Outcome (CPC) After Out-of-Hospital Cardiac Arrest
Time frame: 60 days after ICU admission
Pulsatility index and resistive index of the internal, external, and common carotid arteries, measured within the first 24 hours, at 72 hours, and on days 5-7 after ICU admission, will be analyzed for their association with neurological outcome assessed by the Cerebral Performance Category (CPC) scale.
3 secondary outcomes
Association Between Carotid Doppler Indices and Mortality After Out-of-Hospital Cardiac Arrest
Time frame: 60 days after ICU admission
Association Between Optic Nerve Sheath Diameter and Neurological Outcome and Mortality
Time frame: 60 days after ICU admission
Association Between Cerebral Oximetry (rSO2) and Neurological Outcome and Mortality
Time frame: First 72 hours of ICU stay for measurement; outcomes assessed at 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because patient data are anonymously coded and will not be shared with third parties, in line with the ethics committee approval. Aggregate results will be published in a peer-reviewed journal.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest (CA) and Carotid Doppler, run by Inonu University.
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 1 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Belin Özer, MD (+905534478924, belin.ozer@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Carotid Doppler Indices and Neurological Outcome (CPC) After Out-of-Hospital Cardiac Arrest (time frame: 60 days after ICU admission). 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 5 Nov 2026.