Transcranial Doppler in Traumatic Brain Edema

NCT ID: NCT07107997

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-13
• Study Completion Date: 2025-06-13

Brief Summary

The goal of this clinical trial is to assess the role of transcranial Doppler (TCD) in evaluating brain edema in traumatic brain injury. The main question it aims to answer is:

Is TCD equivalent to brain computerized tomography (CT) in evaluating traumatic brain edema?

Participants will be examined by both methods at the same time to assess the correlation between them.

Detailed Description

Computed Tomography (CT) scan of the brain will be done on admission to the ICU and 48-72 hours after starting hyperosmolar therapy. The cerebral oedema will be scored as follows: 0 = no brain oedema, 1 = mild brain oedema, 2 = moderate brain oedema, and 3 = severe brain oedema. Oedema is defined as mild when the ventricles and cisterns are narrow in the CT in the acute stage; moderate, when in addition to the mild form, the sylvian fissure and cortical gyri are not visualized; and severe, when in addition to mild and moderate, the perimesencephalic cisterns can not be visualized.

Transcranial doppler ultrasonography will be performed immediately after CT scan then after 48-72 hours of starting hyperosmolar therapy according to the following protocol:

• The examination will be done using phased array probe using (Versana active, general electric medical systems china Co.Ltd) ultrasound (US) device.
• Standing behind the head of the patient, the 2 Mega Hertz (MHz) transducer will be placed over the temporal area just above the zygomatic arch and in front of the tragus of the ear and oriented slightly upward and anteriorly.
• A red color signal (i.e. flow towards the probe) at a depth between 40-65 mm will represent the flow in the ipsilateral middle cerebral artery.
• The angle and position of insonation will be adjusted to provide the highest quality Doppler signal.
• By applying pulsed wave on the insonated segment, Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) will be measured and recorded on US machine.
• Mean flow velocity (MFV) will be calculated using the formula:

(PSV+(EDVx 2))/3.

• Pulsatility index (PI) is calculated using the formula: (PSV-EDV)/ MFV.
• Intracranial pressure (ICP) will be calculated as follows:

• CPP is calculated as: MAP*(EDV /MFV) + 14. where MAP is the mean arterial blood pressure.
• ICP is then calculated as: MAP - CPP.

All patients in the study will be managed using the same management principles of traumatic brain injury with raised intracranial pressure such as:

• Hyperosmolar therapy either with 20% mannitol or 3% hypertonic saline.
• Control fever and seizures.
• Elevate head of bed 30-45.
• Adequate analgesia and sedation.
• Maintain systolic blood pressure > 90 mmHg.
• Maintain partial pressure of carbon dioxide (PaCo2) between 35-38 mmHg.
• Maintain partial pressure of oxygen (Pao2) between 80-120 mmHg.
• Avoid hyponatremia.
• Maintain Hb > 9 g/dL.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Traumatic brain injury patients

Traumatic brain injury patients, with brain edema

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with brain edema following traumatic brain injury, admitted within 24 hours

Exclusion Criteria

• Patients presented by out of hospital cardiac arrest or in-hospital cardiac arrest before performing the transcranial Doppler.
• Pregnant females.
• Inability to obtain adequate ultrasound window.
• Temporal bone fracture or brain herniation.
• Open head injuries or patients in need for surgical intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexandria Main University Hospital

Alexandria, Other (Specify), Egypt

Countries

Egypt

Other Identifiers

0108653

Identifier Type: -

Identifier Source: org_study_id