Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491173
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-07-01
Brief Title:
Detecting Traumatic Intracranial Hemorrhage With the InfraScanner 2500 in Uganda
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Assessment of Accuracy Precision and Feasibility of a Handheld Near-Infrared Light Device InfraScanner 2500 in Detecting Traumatic Intracranial Hemorrhage in Uganda
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine the sensitivity specificity and positive and negative predictive values of the portable near-infrared-based device portable NIR-based device the InfraScanner 2500 to detect intracranial hematomas epidural hematomas EDH andor subdural hematomas SDH in patients hospitalized at Mbarara Regional Referral Hospital MRRH or Mayanja Memorial Hospital MMH who have sustained or who are suspected to have sustained head trauma
Detailed Description:
When applicable conscious patient andor 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 andor 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 patients andor representatives 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 or MMH and following each CT scan the study team will approach the patient to scan the patients cranium with the InfraScanner 2500 If permission is granted the study team member sequentially measures the optical absorption for each of the 8 quadrants of the scalp frontal temporal parietal and occipital bilaterally The device is engineered such that the light emitter and receiver are spaced 4 cm apart allowing the lights intensity to be measured between adjacent light guides This entire procedure including greeting and scanning the patient should take 10 minutes Subsequent CT scans the patient receives determines the number of potential data collections
The patient andor representative may refuse a scan during any encounter and as such the scan will not be done For each patient scanned with the InfraScanner 2500 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 andor Microsoft Excel 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 2500 patient discharge or patient death
Upon presentation to the casualty unit at MRRH or MMH and following each CT scan the study team will approach the patient to scan the patients cranium with the InfraScanner 2500 If permission is granted the study team member sequentially measures the optical absorption for each of the 8 quadrants of the scalp frontal temporal parietal and occipital bilaterally The device is engineered such that the light emitter and receiver are spaced 4 cm apart allowing the lights intensity to be measured between adjacent light guides This entire procedure including greeting and scanning the patient should take 10 minutes Subsequent CT scans the patient receives determines the number of potential data collections
The patient andor representative may refuse a scan during any encounter and as such the scan will not be done For each patient scanned with the InfraScanner 2500 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 andor Microsoft Excel 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 2500 patient discharge or patient death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None