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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42040
    • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Fourty patients will be enrolled into this investigation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral performance category (CPS Scale)	Cerebral performance category is described as neurological status after cardiac arrest.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	After CA,1 year mortality	One year

Collaborators and Investigators

• Sponsor: Nevsehir Public Hospital
• Investigators: Principal Investigator: Mehmet Akif Yazar, Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac arrest; Near Infrared Spectroscopy; Optic Nerve Sheath Diameter
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2021-1-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No