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RecruitingNCT06491693Updated Jan 8, 2025

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

An observational study in Optic Nerve Sheath Diameter Measurements for Carotis Endarterectomy, sponsored by Başakşehir Çam & Sakura City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Optic Nerve Sheath Diameter Measurements for Carotis Endarterectomy

Keywords

  • optic nerve sheath dimater
  • carotis endarterectomy
03

In context

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 107 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • BasaksehirCamveSakuraSehirH
    Istanbul, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Mar 2025, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2024
First posted
Jul 9, 2024
StartActual
Jul 1, 2024
Primary completionEst.
Mar 31, 2025
CompletionEst.
Apr 1, 2025
Last update
Jan 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06491693
Responsible party
Zülfiye Yıldız (principal investigator, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
Jul 9, 2024
Start date
Jul 1, 2024
Primary completion
Mar 31, 2025 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Jan 8, 2025

Study contacts

Zulfiye Yildiz, M.D.
Contact
drzulfiye@hotmail.com
5323262605 ext. 0090

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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