Clinical trial NCT03353246: Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Trauma
Craniocerebral Injuries
Crushing Skull Injury
Head Injuries
Head Injuries, Multiple
Head Injuries, Closed
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
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level
timeFrame: Up to 30 days after first CT scan
measure: Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
timeFrame: Up to 30 days after first CT scan
measure: False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
timeFrame: Up to 30 days after first CT scan
measure: False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
timeFrame: Up to 30 days after first CT scan
Secondary outcomes:
measure: Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
timeFrame: Up to 30 days after first CT scan
measure: Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
timeFrame: Up to 30 days after first CT scan
measure: False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
timeFrame: Up to 30 days after first CT scan
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Haglund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: