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

NCT05552794 | Completed

• 1 other identifier: 2021-1-19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Cardiac arrest; Optic Nerve Sheath Diameter; Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Cerebral performance category (CPS Scale)

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

  One year

Secondary Outcomes (1)

• Mortality

  One year

Study Arms (2)

Good outcome

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

Diagnostic Test: Optic nerve Sheath Diameter (ONSD)

Poor outcome

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

Diagnostic Test: Optic nerve Sheath Diameter (ONSD)

Interventions

Optic nerve Sheath Diameter (ONSD) DIAGNOSTIC_TEST

ONSD and rSO2 monitoring will perform when the patients arrived in ICU.

Also known as: Regional cerebral oxygen saturation (rSO2)

Good outcome; Poor outcome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fourty patients will be enrolled into this investigation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nevsehir Public Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mehmet Akif Yazar

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: December 12, 2020
• Primary Completion: March 30, 2022
• Study Completion: August 30, 2022
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

TU (1)