Burr Hole Ultrasound Study

NCT ID: NCT06134206

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-04-24

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Subdural Hematoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

1 Group of 20 patients who all underwent the same examination
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Burr hole sonography

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

Group Type EXPERIMENTAL

Trans-burr hole ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TBUS Trans-burr hole sonography burr hole sonography burr hole ultrasound

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kepler University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harald Stefanits, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Kepler University Hospital Linz, Austria

Locations

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Department of Neurosurgery, Kepler University Hospital

Linz, Upper Austria, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 38647289 (View on PubMed)

Other Identifiers

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EC Nr. 1054/2022

Identifier Type: -

Identifier Source: org_study_id

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