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Active Not Recruiting NCT07816588

TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI

Conditions: Intracranial Pressure Increase, Traumatic Brain Injuries

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Enrollment: 40
Sponsor: Ain Shams University

Location: Ain-Shams University Hospitals Cairo Cairo Governorate

Summary

This study will evaluate two non-invasive ultrasound methods, transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound, for detecting signs of increased intracranial pressure in adults with traumatic brain injury (TBI). The results of these methods will be compared with findings from brain computed tomography (CT), which will be used as the reference assessment. The study will include 40 patients aged 18 to 60 years who are admitted to the intensive care unit with blunt traumatic brain injury and diffuse brain edema on their initial CT scan. TCD and ONSD measurements will be performed by trained operators, together with collection of clinical and physiological data. The study will assess how accurately TCD and ONSD identify CT findings suggestive of increased intracranial pressure and will compare the diagnostic performance of the two methods. Measurements will also be assessed in relation to the severity of CT findings.

Eligibility Criteria

Inclusion Criteria: * Inclusion Criteria: Age 18-60 years. Male and female patients. Patients admitted to the intensive care unit with blunt traumatic brain injury associated with diffuse brain edema on the initial CT brain scan. Patient or legally authorized representative provides informed consent. Exclusion Criteria: Age less than 18 or greater than 60 years. History of vascular disease affecting brain vessels. Pregnant females. Inability to obtain adequate TCD signal from trans-temporal acoustic bone windows due to fusion of skull sutures or temporal bone injury. Significant cardiovascular disease that may affect the TCD signal, such as significant arrhythmia. History of cardiac arrest before admission. Blood flow velocity greater than 120 cm/sec in patients with subarachnoid hemorrhage, to exclude vasospasm as a cause of decreased blood flow. Ocular trauma or orbital surgery that would interfere with ONSD measurement. Chronic hydrocephalus. History of Graves' disease with exophthalmos. History of disease affecting the optic nerve, such as glaucoma. Refusal of consent by the patient or legally authorized representative.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07816588). StuddyBuddy aggregates publicly available trial information.