Cardiac ArrestNCT05552794
Prognostic Value With Combined ONSD and NIRS Measurements for Predicting Neurological Outcome After Cardiac Arrest
An observational study of Cardiac Arrest, run by Nevsehir Public Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cardiac arrest (CA) is a worldwide health problem and is associated with high mortality and morbidity rates. After CA, most patients are exposed to cerebral injury due to anoxic perfusion, resulting in severe neurological deficits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Optic nerve Sheath Diameter (ONSD)
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2020to 30 Aug 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fourty patients will be enrolled into this investigation.
Who may be able to join
- admitted to the ICU after cardiac arrest,
- GCS ≤6 after arrest,
- age ≥18,
- brain tomography taken within the first 6 hours after the arrest,
- targeted heat management (TTM) applied
- sedated patients
Who cannot join
- Patients whose measurements could not be made within the first 24 hours after cardiac arrest (early death, major hemodynamic instability, absence of device or investigator at the weekend),
- cardiac arrest due to intracranial trauma or neurological event,
- patients with previous cerebrovascular accident,
- patients who have affected the orbit or eyeball patients with facial trauma,
- patients with ocular pathology such as exophthalmos, glaucoma or cataracts,
- patients who have been or should be sedated,
- those with recurrent CA within three days of ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value With Combined Sonographic Optic Nerve Sheath Diameter and Near Infrared Spectroscopy Measurements for Predicting Neurological Outcome After Cardiac Arrest
Cardiac arrest (CA) is a worldwide health problem and is associated with high mortality and morbidity rates. After CA, most patients are exposed to cerebral injury due to anoxic perfusion, resulting in severe neurological deficits. Return of spontaneous circulation (ROSC) after KA causes acute cerebral edema with increased intracranial pressure (ICP) due to ischemia-reperfusion and delayed hyperemia, and deterioration of cerebral perfusion. This reduces the quality of life of most patients after cardiac arrest.
Read the detailed description
Accurate and early estimation of adverse neurological outcomes in CA survivors is crucial because null treatments for patients who cannot be saved can be avoided. On the contrary, more detailed and comprehensive treatment protocols can be determined for promising patients. In recent years, some studies have focused on the early prediction of neurological outcomes by evaluating the optic nerve sheath diameter (ONSD) of patients after CA. In order to evaluate acute brain edema, ONSD can be measured by computed tomography (CT), and it has been stated in previous studies that changes in gray-white matter ratio (GWR) may be associated with neurological outcomes. However, in addition to CT, ONSD can be easily measured by bedside ultrasonography. Many studies have found a strong association between increased ICP and sonographic ONSD. However, in some studies, it was stated that ONSD measurements were not correlated with neurological outcomes in the 6-month period after ROSC.
On the other hand, Near-Infrared Spectroscopy (NIRS) measures the total oxygen saturation in a given tissue volume by approximating the oxygen saturation of the hemoglobin fraction in the terminal vasculature. With this method, regional oxygen saturation (rSO2) of the brain tissue can be measured noninvasively. In general, post-hypoxic brain injury after cardiac arrest, changes in oxygen consumption, cerebral blood flow or cerebral blood volume may be associated with rSO2 changes in brain tissue. Therefore, using frontal brain rSO2 continuous bedside NIRS monitoring, additional information can be obtained about the early prediction of reliable neurological outcomes. However, some studies show that reliable prognostic results with NIRS monitoring are limited.
Thanks to the combined use of ultrasonography and bedside noninvasive measurements such as ONSD and NIRS, early prediction of the neurological outcomes of cardiac arrest patients with ROSC can positively change the treatment management of this patient group in ICUs with high sensitivity and better neurological outcomes can be achieved.
In this study, the prognostic values of combined ultrasonographic ONSD and NIRS measurements will investigate in predicting neurological outcomes after cardiac arrest.
- Conditions
- Cardiac Arrest
- Being tested
- Optic nerve Sheath Diameter (ONSD)
- Keywords
- Cardiac arrest, Optic Nerve Sheath Diameter, Near Infrared Spectroscopy
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve Sheath Diameter (ONSD)Diagnostic test
Also called Regional cerebral oxygen saturation (rSO2)
ONSD and rSO2 monitoring will perform when the patients arrived in ICU.
| Study group | Role | What they receive |
|---|---|---|
| Good outcome | Good outcome was defined as cerebral performance category (CPC): 1-2 Receives: Diagnostic Test: Optic nerve Sheath Diameter (ONSD) | |
| Poor outcome | Poor outcome was defined as cerebral performance category (CPC): 3-5 Receives: Diagnostic Test: Optic nerve Sheath Diameter (ONSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral performance category (CPS Scale)
Cerebral performance category is described as neurological status after cardiac arrest.
Measured: One year
Secondary outcomes (1)
Mortality
After CA,1 year mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start12 Dec 2020
- Primary completion30 Mar 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Nevsehir Public Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif Yazar, MD, Nevsehir Public Hospital
- Investigators
- Mehmet Akif Yazar, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552794
- Sponsor's protocol ID
- 2021-1-19
- Status last verified
- Dec 2023
- First submitted
- 20 Sep 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value With Combined Sonographic Optic Nerve Sheath Diameter and Near Infrared Spectroscopy Measurements for Predicting Neurological Outcome After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05552794
- Acronym / sponsor ID
- 2021-1-19
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac arrest, Optic Nerve Sheath Diameter, Near Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nevsehir Public HospitalOther government
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 23 Sep 2022 (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.
Cardiac arrest (CA) is a worldwide health problem and is associated with high mortality and morbidity rates. After CA, most patients are exposed to cerebral injury due to anoxic perfusion, resulting in severe neurological deficits. Return of spontaneous circulation (ROSC) after KA causes acute cerebral edema with increased intracranial pressure (ICP) due to ischemia-reperfusion and delayed hyperemia, and deterioration of cerebral perfusion. This reduces the quality of life of most patients after cardiac arrest.
Detailed description
Accurate and early estimation of adverse neurological outcomes in CA survivors is crucial because null treatments for patients who cannot be saved can be avoided. On the contrary, more detailed and comprehensive treatment protocols can be determined for promising patients. In recent years, some studies have focused on the early prediction of neurological outcomes by evaluating the optic nerve sheath diameter (ONSD) of patients after CA. In order to evaluate acute brain edema, ONSD can be measured by computed tomography (CT), and it has been stated in previous studies that changes in gray-white matter ratio (GWR) may be associated with neurological outcomes. However, in addition to CT, ONSD can be easily measured by bedside ultrasonography. Many studies have found a strong association between increased ICP and sonographic ONSD. However, in some studies, it was stated that ONSD measurements were not correlated with neurological outcomes in the 6-month period after ROSC.
On the other hand, Near-Infrared Spectroscopy (NIRS) measures the total oxygen saturation in a given tissue volume by approximating the oxygen saturation of the hemoglobin fraction in the terminal vasculature. With this method, regional oxygen saturation (rSO2) of the brain tissue can be measured noninvasively. In general, post-hypoxic brain injury after cardiac arrest, changes in oxygen consumption, cerebral blood flow or cerebral blood volume may be associated with rSO2 changes in brain tissue. Therefore, using frontal brain rSO2 continuous bedside NIRS monitoring, additional information can be obtained about the early prediction of reliable neurological outcomes. However, some studies show that reliable prognostic results with NIRS monitoring are limited.
Thanks to the combined use of ultrasonography and bedside noninvasive measurements such as ONSD and NIRS, early prediction of the neurological outcomes of cardiac arrest patients with ROSC can positively change the treatment management of this patient group in ICUs with high sensitivity and better neurological outcomes can be achieved.
In this study, the prognostic values of combined ultrasonographic ONSD and NIRS measurements will investigate in predicting neurological outcomes after cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good outcome | – | Diagnostic Test: Optic nerve Sheath Diameter (ONSD)Good outcome was defined as cerebral performance category (CPC): 1-2 |
| Poor outcome | – | Diagnostic Test: Optic nerve Sheath Diameter (ONSD)Poor outcome was defined as cerebral performance category (CPC): 3-5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fourty patients will be enrolled into this investigation.
Key inclusion criteria (6 listed)
- admitted to the ICU after cardiac arrest,
- GCS ≤6 after arrest,
- age ≥18,
- brain tomography taken within the first 6 hours after the arrest,
- targeted heat management (TTM) applied
Key exclusion criteria (7 listed)
- Patients whose measurements could not be made within the first 24 hours after cardiac arrest (early death, major hemodynamic instability, absence of device or investigator at the weekend),
- cardiac arrest due to intracranial trauma or neurological event,
- patients with previous cerebrovascular accident,
- patients who have affected the orbit or eyeball patients with facial trauma,
- patients with ocular pathology such as exophthalmos, glaucoma or cataracts,
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 |
|---|---|---|
| Optic nerve Sheath Diameter (ONSD)Also: Regional cerebral oxygen saturation (rSO2)ONSD and rSO2 monitoring will perform when the patients arrived in ICU. | Diagnostic test | Good outcome, Poor outcome |
Primary outcome
Cerebral performance category (CPS Scale)
Time frame: One year
Cerebral performance category is described as neurological status after cardiac arrest.
1 secondary outcome
Mortality
Time frame: One year
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 2 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Akif Yazar principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Nevsehir Public Hospital 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 6 inclusion and 7 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 2 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?
Cerebral performance category (CPS Scale) (time frame: One year). 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 2 Jan 2024.