3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages

N/AActive Not RecruitingNCT06780436

The Geneva Foundation20 enrolled

Overview

The primary objective of this study is to assess the safety of the 3D Transcranial Ultrasound Brain Imaging (3D TRUBI) device in Traumatic Brain Injury (TBI) patients with intracranial hemorrhage (ICH). The secondary objective is to assess the diagnostic potential of 3D TRUBI. The latter will be achieved by comparison of 3D TRUBI scans with admission head computed tomography (CT), the standard of care diagnostic modality. Demonstrating the feasibility and safety of the 3D TRUBI system is the first step toward expanding access of an alternative to CT for diagnostic imaging and triage of mass casualties of war or natural disasters in the field and in rapidly deployed medical centers or other austere environments.

Eligible participants positive for intracranial hemorrhage (ICH) due to traumatic brain injury (TBI) will undergo a full scanning procedure by trained investigators. Examination with the 3D TRUBI system will involve acquisition of 16 pre-defined bilateral head points. The total time to complete the procedure is approximately 20 minutes. During the examination, feasibility and safety metrics will be collected. Additional injury data will be reviewed from participants' electronic medical record. The goal of the study is 1) to evaluate the safety of the 3D TRUBI device in the target population and 2) do demonstrate the feasibility of the device to detect ICH compared to standard medical imaging.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Traumatic Brain Hemorrhage Traumatic Brain Injury Intracranial Hemorrhages

Interventions

3D Transcranial Ultrasound Brain ImagingDEVICE

The system implements a proprietary transcranial imaging methodology, which measures the profile of the skull bone and the speed of sound in it to accurately focus the ultrasound energy from a phased array probe through the bone in order to detect hematoma boundaries with resolution normally obtainable only through the open skull.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-89 * Acute head injury with CT-confirmed intracranial hemorrhage * Able to obtain written, informed consent from participant or legally authorized representative * Able to receive intervention within 4 hours of admission head CT * Able to feasibly receive intervention prior to neurosurgical indication Exclusion Criteria: * Did not receive routine head CT * Prisoner or Wards of State * Large or open skull wounds prohibiting ultrasound acquisition * Received large volume fluid resuscitation (e.g. \>3 units of blood product) within 2 hours of intervention * Any prohibiting condition or contraindication for ultrasound image acquisition

Outcomes

Primary Outcomes

Feasibility of Intracranial Hemorrhage Detection

The primary outcome is the assessment of the feasibility of 3D-TRUBI for the detection of ICH and other traumatic brain lesions as compared to admission head CT. This is a binary parameter for each type of lesion per patient.

Time frame: From enrollment to the end of data analysis (18 months)

Evaluation of potential adverse effects

Participants will be evaluated for any potential adverse reactions to performance of the TRUBI exam during and after the research procedure. Twenty-four and 48-hour examination of the head are also planned to record potential adverse reactions.

Time frame: up to 48 hours after enrollment

Secondary Outcomes

Morphometric comparison of 3D-TRUBI with Standard Radiology

If the ICH lesion is detectable on CT, the conventional morphometric analysis of the lesion (maximum thickness, width, and length) and midline shift will be compared with morphometric analysis of the same lesions on 3D-TRUBI images. Measurements of ICH lesions by both modalities will be done in mm (millimeters), so there will be direct numerical comparisons of results using descriptive statistics, and other types of correlation and regression analyses.

Time frame: From enrollment to end of data analysis (18 months)

Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage

To address feasibility of deployment of the 3D-TRUBI for ICH detection in the acute care setting, we will collect and analyze the time required to recruit, enroll, initiate, complete, and (where appropriate) repeat the assessment for ICH detection.

Time frame: From enrollment to discharge of subject (7 days)