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

Primary Purpose

Increased Intracranial Pressure

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
doppler study of central retinal artery
Sponsored by
Inas Ahmed Sayed Ammar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Increased Intracranial Pressure

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo university Kas AL- Ainy Fuculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group (N)

Intervention group (H)

Arm Description

Central retinal artery Doppler in patient with normal ICP

Central retinal artery Doppler in patient with increased ICP

Outcomes

Primary Outcome Measures

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 .
peak systolic velocity ( cm/s)
on a doppler waveform PSV correspond to each tall "peak " in the spectrum window calculated by build in software
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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2023
Last Updated
October 13, 2023
Sponsor
Inas Ahmed Sayed Ammar
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1. Study Identification

Unique Protocol Identification Number
NCT05891678
Brief Title
The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP
Official Title
The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2025 (Anticipated)
Study Completion Date
October 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inas Ahmed Sayed Ammar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Increased Intracranial Pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (N)
Arm Type
No Intervention
Arm Description
Central retinal artery Doppler in patient with normal ICP
Arm Title
Intervention group (H)
Arm Type
Active Comparator
Arm Description
Central retinal artery Doppler in patient with increased ICP
Intervention Type
Radiation
Intervention Name(s)
doppler study of central retinal artery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Central retinal artery resistivity index
Description
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 .
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
Title
peak systolic velocity ( cm/s)
Description
on a doppler waveform PSV correspond to each tall "peak " in the spectrum window calculated by build in software
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
Title
end diastolic velocity ( cm/s )
Description
on a doppler waveform EDV correspond to the point marked at the end of the cardiac cycle calculated by build in software
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cairo university Kas AL- Ainy Fuculty of medicine
City
Cairo
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Ibrahim Elsayed, Medical Doctorate degree
Phone
01065115685
Ext
+2
Email
ahmed.mohamed33470@postgrad.kasralainy.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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