Burr Hole Ultrasound Study

Sponsor

Kepler University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06134206

Collaborator

(none)

Enrollment

Location

Arm

11.8

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Subdural Hematoma	Diagnostic Test: Trans-burr hole ultrasound	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

1 Group of 20 patients who all underwent the same examination1 Group of 20 patients who all underwent the same examination

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 1, 2022

Actual Primary Completion Date :

Apr 18, 2023

Actual Study Completion Date :

Apr 24, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Burr hole sonography Patients within this arm (only arm of the study) undergo burr hole sonography	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. Other Names: TBUS Trans-burr hole sonography burr hole sonography burr hole ultrasound

Arm

Intervention/Treatment

Experimental: Burr hole sonography

Patients within this arm (only arm of the study) undergo burr hole sonography

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.

Other Names:

TBUS

Trans-burr hole sonography

burr hole sonography

burr hole ultrasound

Outcome Measures

Primary Outcome Measures

cSDH thickness [1 measurement on day 3-7 postoperative]
maximum extent of the hematoma (chronic subdural hematoma, CSDH) thickness under the burr hole in axial and coronal plane

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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