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

January 7, 2025 updated by: Zülfiye Yıldız, Başakşehir Çam & Sakura City Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • BasaksehirCamveSakuraSehirH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 4 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Başakşehir Çam & Sakura City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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