Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital: A Pilot Study

The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).

Study Overview

• Status: Completed
• Conditions: Head Injuries, Closed; Head Trauma; Head Injuries; Craniocerebral Injuries; Crushing Skull Injury; Head Injuries, Multiple; Head Trauma,Closed; Head Trauma Injury; Head Trauma, Penetrating; Head Injury, Minor; Head Injury Major; Head Injury, Open; Injuries, Craniocerebral; Injuries, Head; Multiple Head Injury; Trauma, Head
• Intervention / Treatment: Device: InfraScanner 2000™

Detailed Description

When applicable (conscious patient and/or family or legally authorized representative is present) the study will be introduced to the patient and relevant parties prior to the research team approaching the patient. While head trauma frequently results in impaired cognition and/or consciousness, and due to the urgency of these circumstances patients are often not accompanied by kin, whenever appropriate, the purpose of the research and the procedure will be explained in detail with all questions answered to the patient's and/or representative's satisfaction. Because patients who sustain head trauma injuries typically remain within the hospital for multiple days for monitoring and care, each participant may undergo multiple CT scans over the course of his or her hospitalization, affording the opportunity to one to numerous measurements from each patient during his or her hospital stay.

Within 30 minutes following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). The procedure will entail placing 8 plastic light guides upon the patient's scalp. The study team member will use the device to sequentially emit light through each of the 8 light guides so that the light is incident upon scalp (Image B). The device is engineered such that the light emitter and receiver are spaced ~4cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting the patient, placing the light guides, gathering the data, and removing the light guides should take ~10 minutes each time. The number of CT scans the patient receives determines the number of potential data collections. The patient will be approached by the study team following each CT scan to be scanned with the InfraScanner 2000™ (20). The patient and/or representative may refuse a scan during any encounter, and as such, the scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be de-identified with a subject number, with age, sex, gender, skin color, hair color, hair thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT scan and near-infrared measurement. These data will be stored in de-identified form on Research Electronic Data Capture (REDCap) and/or Microsoft Excel 2016 on a secured DHTS server (S:\NSU_IRB\Pro00087011).

The collection period for each research subject concludes 30-days following his or her initial measurement with the InfraScanner 2000™, patient discharge, or patient death.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient who presents to Duke University Hospital with suspected head trauma and receives a brain CT scan will be considered for this study.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: InfraScanner 2000™; All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.

Device: InfraScanner 2000™; The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level	Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level	Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level	Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level	Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level	Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level	Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level	Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level	Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level	Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level	Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level	Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level	Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level	Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level	Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.	Up to 30 days after first CT scan

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2017
• Primary Completion (ACTUAL): May 4, 2018
• Study Completion (ACTUAL): May 4, 2018

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (ACTUAL): November 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Trauma, Nervous System; Intracranial Hemorrhages; Wounds, Nonpenetrating; Wounds, Penetrating; Intracranial Hemorrhage, Traumatic; Wounds and Injuries; Multiple Trauma; Craniocerebral Trauma; Hematoma; Head Injuries, Closed; Head Injuries, Penetrating; Hematoma, Epidural, Cranial; Hematoma, Epidural, Spinal
• Other Study ID Numbers: Pro00087011

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: Yes
• product manufactured in and exported from the U.S.: No