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Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

Primary Purpose

Head Trauma, Craniocerebral Injuries, Crushing Skull Injury

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
InfraScanner 2000™
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head Trauma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient who presents to MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda will be considered for this study.

Exclusion Criteria:

  • None

Sites / Locations

  • Duke University Medical Center
  • Mbarara Regional Referral Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

InfraScanner 2000™

Arm Description

All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. 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.

Outcomes

Primary Outcome Measures

Detection of hematomas
Determine whether the InfraScanner 2000™ detects epidural and/or subdural hematomas with adequate precision relative to CT scans to be used as a diagnostic tool for epidural and/or subdural hematomas.

Secondary Outcome Measures

Estimate test characteristics
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL and depth <2.5 cm) compared to CT scan results as the gold standard.
Estimate patient outcomes
Clinical patient outcomes as measured by the Glasgow Outcomes Scale at discharge and 30 days post-discharge. The Glasgow Outcomes Scale is rated from 1 to 8, 1 being death, and 8 being upper good recovery.
Identify reasons CT not performed
CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.
Identify causes of head trauma
Causes of head trauma will be identified through the medical record

Full Information

First Posted
July 22, 2020
Last Updated
August 15, 2022
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04505293
Brief Title
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 and Mbarara Regional Referral Hospital: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
June 29, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
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 Computed Tomography (CT) scans over the course of his or her hospitalization, affording the opportunity of one to numerous measurements from each patient during his or her hospital stay. Upon presentation to the casualty unit at MRRH and following each CT scan, the study team will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image A). If permission is granted, the study team member sequentially measure the optical absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and occipital bilaterally) (Image B). The device is engineered such that the light emitter and receiver are spaced 4 cm apart, allowing the light's intensity to be measured between adjacent light guides (Image C). This entire procedure, including greeting and scanning the patient should take <10 minutes. Subsequent CT scan(s) the patient receives determines the number of potential data collections. 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 the Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured network drive within the Department of Neurosurgery at Duke. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
672 (Actual)

8. Arms, Groups, and Interventions

Arm Title
InfraScanner 2000™
Arm Type
Experimental
Arm Description
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. 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.
Intervention Type
Device
Intervention Name(s)
InfraScanner 2000™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection of hematomas
Description
Determine whether the InfraScanner 2000™ detects epidural and/or subdural hematomas with adequate precision relative to CT scans to be used as a diagnostic tool for epidural and/or subdural hematomas.
Time Frame
Within 30 minutes following each CT scan
Secondary Outcome Measure Information:
Title
Estimate test characteristics
Description
Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL and depth <2.5 cm) compared to CT scan results as the gold standard.
Time Frame
18 months after study is closed to accrual
Title
Estimate patient outcomes
Description
Clinical patient outcomes as measured by the Glasgow Outcomes Scale at discharge and 30 days post-discharge. The Glasgow Outcomes Scale is rated from 1 to 8, 1 being death, and 8 being upper good recovery.
Time Frame
Through study completion, defined as 30 days following discharge
Title
Identify reasons CT not performed
Description
CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.
Time Frame
Through study completion, defined as 30 days following discharge
Title
Identify causes of head trauma
Description
Causes of head trauma will be identified through the medical record
Time Frame
Through study completion, defined as 30 days following discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient who presents to MRRH with suspected head trauma, who is able to or who has a legally authorized representative who is able consent in English, Swahili, or Luganda will be considered for this study. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Haglund, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Mbarara Regional Referral Hospital
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas

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