Prognostic Value With Combined ONSD and NIRS Measurements for Predicting Neurological Outcome After Cardiac Arrest

Sponsor
Nevsehir Public Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05552794
Collaborator
(none)
40
1
20.6
1.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Optic nerve Sheath Diameter (ONSD)

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prognostic Value With Combined Sonographic Optic Nerve Sheath Diameter and Near Infrared Spectroscopy Measurements for Predicting Neurological Outcome After Cardiac Arrest
Actual Study Start Date :
Dec 12, 2020
Actual Primary Completion Date :
Mar 30, 2022
Actual Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Good outcome

Good outcome was defined as cerebral performance category (CPC): 1-2

Diagnostic Test: Optic nerve Sheath Diameter (ONSD)
ONSD and rSO2 monitoring will perform when the patients arrived in ICU.
Other Names:
  • Regional cerebral oxygen saturation (rSO2)
  • Poor outcome

    Poor outcome was defined as cerebral performance category (CPC): 3-5

    Diagnostic Test: Optic nerve Sheath Diameter (ONSD)
    ONSD and rSO2 monitoring will perform when the patients arrived in ICU.
    Other Names:
  • Regional cerebral oxygen saturation (rSO2)
  • Outcome Measures

    Primary Outcome Measures

    1. Cerebral performance category [One year]

      Cerebral performance category is described as neurological status after cardiac arrest.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konya City Hospital Konya Turkey 42040

    Sponsors and Collaborators

    • Nevsehir Public Hospital

    Investigators

    • Principal Investigator: Mehmet Akif Yazar, Konya City Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mehmet Akif Yazar, Assoc. Prof., Nevsehir Public Hospital
    ClinicalTrials.gov Identifier:
    NCT05552794
    Other Study ID Numbers:
    • 2021-1-19
    First Posted:
    Sep 23, 2022
    Last Update Posted:
    Sep 23, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mehmet Akif Yazar, Assoc. Prof., Nevsehir Public Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2022