Burr Hole Ultrasound Study

November 12, 2023 updated by: Kepler University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Department of Neurosurgery, Kepler University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cSDH thickness
Time Frame: 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
1 measurement on day 3-7 postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kepler University Hospital

Investigators

  • Principal Investigator: Harald Stefanits, MD, PhD, Department of Neurosurgery, Kepler University Hospital Linz, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

April 24, 2023

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC Nr. 1054/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Subdural Hematoma

Clinical Trials on Trans-burr hole ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe