Burr Hole Ultrasound Study

Chronic Subdural Hematoma Clinical Trial

Official title:

Evaluation of the Feasibility of Measuring Chronic Subdural Hematoma Thickness Via Trans-burrhole Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06134206
• Other study ID #: EC Nr. 1054/2022
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 24, 2023

Study information

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

Clinical Trial Summary

Chronic subdural hematoma (CSDH) is commonly managed through burr hole evacuation. This study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality.

A pilot study on 20 patients who underwent burr hole surgery for CSDH was therefore planned. Postoperative imaging included both CT and sonographic examinations through the burr hole. We assessed the ability to measure residual subdural fluid thickness sonographically compared to CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 24, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Burr hole surgery due to chronic subdural hematoma

• Routine performance of an computed tomography scan within 3-7 days postoperative

• Ability to give informed consent

Exclusion Criteria:

• Performance of prior craniotomy

• Performance of prior revision surgery

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Diagnostic Test:
• Trans-burr hole ultrasound
All ultrasound examinations were conducted alongside the routine postoperative CT scan between 3-7 days postoperatively. To minimize potential influences of the patient's head position on the distribution and thickness of the subdural fluid, we first carried out the CT scan with the patient and their head in a supine position. Immediately after the CT scan, the patient remained on the same examination bed, and burr hole ultrasound was performed in the identical supine position. The burr hole was centered in the image, with the outer table surrounding the burr hole displayed as a horizontal line. The content of the burr hole could be differentiated by its higher echogenicity from the subdural residual hematoma or residual fluid. The brain's surface and overlying leptomeninges, however, displayed higher echogenicity compared to the subdural fluid. The subdural hematoma's thickness was measured at its maximum extent.

Locations

Country	Name	City	State
Austria	Department of Neurosurgery, Kepler University Hospital	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Kepler University Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cSDH thickness	maximum extent of the hematoma (chronic subdural hematoma, CSDH) thickness under the burr hole in axial and coronal plane	1 measurement on day 3-7 postoperative