The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP

Increased Intracranial Pressure Clinical Trial

Official title:

The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05891678
• Other study ID #: CRA doppler in increased ICP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: October 15, 2025

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure.

Description:

In neurocritical care, the detection of raised intracranial pressure (ICP) remains crucial as it is associated with poor outcome . Invasive ventricular devices are the gold standard for continuous and reliable measurement of ICP however their placement could be challenging due to blood coagulation disorder or lack of surgical availability. Moreover, malfunction or obstruction of ventricular catheters has been reported to occur as often as 6%. Recently Julie.et al. revealed in his met analysis that optic nerve sheath diameter (ONSD) has a good level of diagnostic accuracy for detecting intracranial hypertension with a pooled sensitivity of 0.9. The central retinal artery (CRA) is an end artery branch of the internal carotid artery that joins the optic nerve 1cm behind the globe and enters the retina on the optic nerve head . Central retinal artery is located inside the optic nerve sheath, and The optic nerve is part of the central nervous system and the intraorbital subarachnoid space surrounding the optic nerve is subject to the same pressure changes as the intracranial compartment,so we should expect any increase of ICP will compress the central retinal artery exactly the same as basal cerebral arteries. Central retinal artery circulation is low resistance circulation with good diastolic flow and upper limit of resistivity index is 0.7. So, any compression of CRA will decrease the diastolic flow and increase RI. Kamil.et al. studied the blood flow velocity changes in orbital arteries by using Doppler sonography in eight patients with brain death and increased ICP. Peak systolic and end-diastolic velocities and resistive indices of the ophthalmic and central retinal arteries were evaluated. they observed the absence or reversal of end diastolic blood flow in these arteries. If the intracranial pressure is higher than the end-diastolic pressure of the cerebral arteries diastolic flow reversal occurs. If the intracranial pressure exceeds systolic pressure blood flow is entirely ceased with complete and irreversible loss of brain function CRA is a superficial, easy accessible without bony obstacle like transcranial doppler (TCD) and the learning curve of its Doppler study can be very steep, so it could has a big role in management of cases with increased ICP.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 66
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• All Patients with cerebral stroke either ischemic or hemorrhagic
• All Patients with traumatic brain injury including those on mechanical ventilation

Exclusion Criteria:

• Patients with eye trauma
• Patients with either arteritic or non arteritic central retinal artery occlusion

Related Conditions & MeSH terms

• Increased Intracranial Pressure
• Intracranial Hypertension

Intervention

Radiation:
• doppler study of central retinal artery
pulsed wave Doppler after decreasing the sample volume to fit inside the center of CRA. We will measure the peak systolic velocity (PSV), end diastolic velocity (EDV), and the resistivity index which equal PSV-EDV/PSV, we will measure 3 times and the expected normal value is less than 0.7.

Locations

Country	Name	City	State
Egypt	Cairo university Kas AL- Ainy Fuculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Inas Ahmed Sayed Ammar

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central retinal artery resistivity index	Central retinal artery resistivity index computed by PSV (cm/s ) and EDV (cm/s) reflects vascular resistance peripheral to the measuring location. The present study evaluate the correlation of Central retinal artery resistive index with increased intracranial pressure .	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Primary	peak systolic velocity ( cm/s)	on a doppler waveform PSV correspond to each tall "peak " in the spectrum window calculated by build in software	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Primary	end diastolic velocity ( cm/s )	on a doppler waveform EDV correspond to the point marked at the end of the cardiac cycle calculated by build in software	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months