Can Optic Nerve Sheath Diameter Detect Norological Morbidities for Patients Undergoing Carotis Endarterectomy

Can Ultrasonographic Screening of Optic Sheath Diameter Be an Early Detector of Norological Morbidities Related Carotis Endarterectomy

The main purpose of this study is to investigate the contribution of changes in Optic Nerve Sheath Diameter (OSNC) measured at different periods during Carotid Endarterectomy (CEA) operations to the prediction of neurological problems detected in the postoperative period. The secondary aim of the study is to examine the relationship between optic nerve sheath diameter measurement and other routinely used perioperative follow-up parameters in terms of predicting neurological problems.

Study Overview

• Status: Recruiting
• Conditions: Optic Nerve Sheath Diameter Measurements for Carotis Endarterectomy

Detailed Description

CEA operations are generally performed on elderly patients and patients with different comorbidities. These patients have carotid artery stenosis and often thrombus. 85% of all stroke cases are due to ischemic causes, and 15-30% of them are due to carotid artery stenosis. The treatment method is usually surgery. CEA operations. Early detection of cerebral hypoperfusion and ischemia during the operation is important. Carotid clamp applications, which must be used during the operation upon the decision of the surgical team, may cause cerebral hypoperfusion. In addition, the resulting systemic hypotension further worsens this situation. In order to prevent cerebral hypoperfusion, carotid shunt applications can be performed to ensure flow continuity, and at the same time, cerebral hypoperfusion is tried to be prevented by keeping the mean arterial pressure high. Close monitoring of these cases and follow-up of cerebral perfusion adequacy is important to detect ischemia and embolism events that may develop especially during these periods. ECG, blood pressure, oxygen saturation, near infrared spectroscopy (NIRS), and Bispectral index (BIS) are routinely used in monitoring. In addition, it is reported in the literature that there are changes in ONCH, which can be easily evaluated with USG, in cases such as ischemic stroke and increased intracranial pressure, an increasing trend occurs and shows an excellent correlation with invasive intracranial pressure monitoring. ONSD has been associated with increases in intracranial pressure. In these patients in whom a carotid clamp is placed, an increase in intracranial pressure due to ischemia and cerebral hypoperfusion and a corresponding increase in ONSD may be observed. In this context, in our study, in addition to routine monitoring methods, we measured the Optic Nerve Sheath Diameter (OSCN), which can be examined practically with the help of ultrasonography (USG), which we use in our daily practice in the operating room, and does not require any additional cost and labor, and thus, we measured the parameters such as cerebral ischemia and increased intracranial pressure that may develop in the intraoperative period. We planned to investigate its contribution to the prediction of neurological problems and its relationship with other follow-up parameters. Measurement of ONSC with USG is a very simple, noninvasive and non-harmful method.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Zulfiye Yildiz, M.D.; Phone Number: 0090 5323262605; Email: drzulfiye@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • BasaksehirCamveSakuraSehirH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

It was planned to include 40 patients, male and female, between the ages of 50 and 80, who were scheduled for elective CEA under general anesthesia, taking into account previous similar studies (1,3,4) and power analysis.

Description

Inclusion Criteria:

• Male and female patients between the ages of 50 and 80, who are planned for elective CEA under general anesthesia, who come in a spontaneously breathing, conscious and cooperative state.

Exclusion Criteria:

• Patients who are under 50 years of age, over 80 years of age, have neurological findings caused by reasons other than carotid lesion, and are intubated.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The aim is to investigate the contribution of changes in Optic Nerve Sheath Diameter (OSNC) measured at different periods during Carotid Endarterectomy (CEA) operations to the prediction of neurological problems detected in the postoperative period.	Optic nerve sheath diameter measurement with USG is made using a high-frequency linear probe after the system settings are made suitable for the lens retina and vitreous body. It is performed by applying gel to the upper eyelid and placing the transducer in the temporal part of the eye, with the patient in a supine position with the head and body elevated 20-30 degrees.Optic nerve sheath diameter measurement with USG is made using a high-frequency linear probe after the system settings are made suitable for the lens retina and vitreous body. It is performed by applying gel to the upper eyelid and placing the transducer in the temporal part of the eye, with the patient in a supine position with the head and body elevated 20-30 degrees.	4 months

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: optic nerve sheath dimater; carotis endarterectomy
• Other Study ID Numbers: KAEK-11/22.05.2024.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No