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

November 27, 2023 updated by: Inas Ahmed Sayed Ammar
The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Cairo university Kas AL- Ainy Fuculty of medicine

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group (N)
Central retinal artery Doppler in patient with normal ICP
Active Comparator: Intervention group (H)
Central retinal artery Doppler in patient with increased ICP
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central retinal artery resistivity index
Time Frame: 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
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
peak systolic velocity ( cm/s)
Time Frame: 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
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
end diastolic velocity ( cm/s )
Time Frame: 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
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

Collaborators and Investigators

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

Sponsor

Inas Ahmed Sayed Ammar

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)

October 15, 2023

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRA doppler in increased ICP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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