Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491693
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
Can Optic Nerve Sheath Diameter Detect Norological Morbidities for Patients Undergoing Carotis Endarterectomy
Sponsor:
Başakşehir Çam Sakura City Hospital
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Can Ultrasonographic Screening of Optic Sheath Diameter Be an Early Detector of Norological Morbidities Related Carotis Endarterectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None