Burr Hole Ultrasound Study

NCT06134206 | Completed

• 1 other identifier: EC Nr. 1054/2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

Burr hole; Ultrasound; Trans-burr hole; TBUS; Sonography; Chronic Subdural hematoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Burr hole sonography

EXPERIMENTAL

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

Diagnostic Test: Trans-burr hole ultrasound

Interventions

Trans-burr hole ultrasound DIAGNOSTIC_TEST

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.

Also known as: TBUS, Trans-burr hole sonography, burr hole sonography, burr hole ultrasound

Burr hole sonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Performance of prior craniotomy
• Performance of prior revision surgery

Sponsors & Collaborators

• Kepler University Hospital: lead

Study Sites (1)

Department of Neurosurgery, Kepler University Hospital

Linz, Upper Austria, 4020, Austria

Location

Related Publications (1)

• Aspalter S, Gmeiner M, Gasser S, Sonnberger M, Stroh N, Rauch P, Gruber A, Stefanits H. Feasibility, Clinical Potential, and Limitations of Trans-Burr Hole Ultrasound for Postoperative Evaluation of Chronic Subdural Hematoma: A Prospective Pilot Study. Neurosurgery. 2024 Oct 1;95(4):924-931. doi: 10.1227/neu.0000000000002957. Epub 2024 Apr 22.

  PMID: 38647289 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Harald Stefanits, MD, PhD

  Department of Neurosurgery, Kepler University Hospital Linz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 Group of 20 patients who all underwent the same examination

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: May 1, 2022
• Primary Completion: April 18, 2023
• Study Completion: April 24, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)