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| Name | Class |
|---|---|
| Mbarara Regional Referral Hospital | UNKNOWN |
| Mayanja Memorial Hospital | UNKNOWN |
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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) and/or 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.
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 or MMH and following each CT scan, the study team will approach the patient to scan the patient's 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 light's intensity to be measured between adjacent light guides. 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 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 and/or 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InfraScanner 2500™ | Experimental | All patients entered into the trial will undergo at least one cranial scanning using the InfraScanner 2500™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2500™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2500™. 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 2500™ are positive consideration of further follow-up will be given on a case-by-case basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InfraScanner 2500™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infrascanner 2500™ Diagnostic Performance | Number of participants with detection of intracranial hemorrhage (ICH) by the InfraScanner 2500™ stratified by CT Positive and CT Negative using the CT as the gold standard for ICH presence. | Within 30 minutes following CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™ | The accuracy of the Infrascanner 2500™ reported through the sensitivity of intracranial hemorrhage (ICH) detection (as compared to CT findings). Sensitivity measures the ability to identify true positives. | Within 30 minutes following CT scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Kolls, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayanja Memorial Hospital | Mbarara | Uganda | ||||
| Mbarara Regional Referral Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29701556 | Background | Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM, Rosenfeld JV, Park KB. Estimating the global incidence of traumatic brain injury. J Neurosurg. 2018 Apr 27;130(4):1080-1097. doi: 10.3171/2017.10.JNS17352. Print 2019 Apr 1. | |
| 35697226 | Background | Veerappan VR, Gabriel PJ, Shlobin NA, Marks K, Ooi SZY, Aukrust CG, Ham E, Abdi H, Negida A, Park KB, El Ouahabi A. Global Neurosurgery in the Context of Global Public Health Practice-A Literature Review of Case Studies. World Neurosurg. 2022 Sep;165:20-26. doi: 10.1016/j.wneu.2022.06.022. Epub 2022 Jun 11. |
| Label | URL |
|---|---|
| InfraScan. Infrascanner - White Paper A Handheld Brain Hematoma Detector. Accessed February 4, 2024. | View source |
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186 consented/assessed; 6 excluded pre-assignment due to inability to obtain protocol-required CT or Infrascanner measurement (scalp/hair access or not completed within 30 min of CT), or ineligibility (post-neurosurgery in-hospital TBI, no presenting head trauma). Participants who consented but could not complete required device measurements were considered screen failures and were not assigned/enrolled. Thus 180 were assigned/enrolled.
Participants were recruited from a patient population presenting with suspected head trauma at MRRH and MMH, in Mbarara, Uganda. Patients ages 13 and above, able to give consent themselves or have a legally authorized representative (LAR) who could consent in English, Runyankole, or Luganda. Criteria excluded patients for whom could not obtain complete Infrascanner 2500™ measurements within 30 minutes of their CT scan. Recruitment started July 30th, 2024 and ended February 28th, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | InfraScanner 2500™ | All patients entered into the trial will undergo at least one cranial scanning using the InfraScanner 2500™ upon arrival to the casualty unit at MRRH or MMH following CT. Patients will be scanned using the InfraScanner 2500™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2500™. 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 2500™ are positive consideration of further follow-up will be given on a case-by-case basis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2024 |
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| Specificity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™ |
The accuracy of the Infrascanner 2500™ reported through the specificity of intracranial hemorrhage (ICH) detection (as compared to CT findings). Specificity measures the ability to identify true negatives. |
| Within 30 minutes following CT scan |
| Mbarara |
| Uganda |
| 35962968 | Background | Ukachukwu AK, Still MEH, Seas A, von Isenburg M, Fieggen G, Malomo AO, Shokunbi MT, Egger JR, Haglund MM, Fuller AT. Fulfilling the specialist neurosurgical workforce needs in Africa: a systematic review and projection toward 2030. J Neurosurg. 2022 Aug 12;138(4):1102-1113. doi: 10.3171/2022.2.JNS211984. Print 2023 Apr 1. |
| 16624322 | Background | Janca A, Aarli JA, Prilipko L, Dua T, Saxena S, Saraceno B. WHO/WFN Survey of neurological services: a worldwide perspective. J Neurol Sci. 2006 Aug 15;247(1):29-34. doi: 10.1016/j.jns.2006.03.003. Epub 2006 Apr 19. |
| 27506722 | Background | Ttendo SS, Was A, Preston MA, Munyarugero E, Kerry VB, Firth PG. Retrospective Descriptive Study of an Intensive Care Unit at a Ugandan Regional Referral Hospital. World J Surg. 2016 Dec;40(12):2847-2856. doi: 10.1007/s00268-016-3644-5. |
| 32235768 | Background | Vaca SD, Feng AY, Ku S, Jin MC, Kakusa BW, Ho AL, Zhang M, Fuller A, Haglund MM, Grant G. Boda Bodas and Road Traffic Injuries in Uganda: An Overview of Traffic Safety Trends from 2009 to 2017. Int J Environ Res Public Health. 2020 Mar 22;17(6):2110. doi: 10.3390/ijerph17062110. |
| 34415855 | Background | Firth PG, Mushagara R, Musinguzi N, Liu C, Boatin AA, Mugabi W, Kayaga D, Naturinda P, Twesigye D, Sanyu F, Mugyenyi G, Ngonzi J, Ttendo SS; Mbarara SQUAD Consortium. Surgical, Obstetric, and Anesthetic Mortality Measurement at a Ugandan Secondary Referral Hospital. Anesth Analg. 2021 Dec 1;133(6):1608-1616. doi: 10.1213/ANE.0000000000005734. |
| 17352796 | Background | Hyam JA, Welch CA, Harrison DA, Menon DK. Case mix, outcomes and comparison of risk prediction models for admissions to adult, general and specialist critical care units for head injury: a secondary analysis of the ICNARC Case Mix Programme Database. Crit Care. 2006;10 Suppl 2(Suppl 2):S2. doi: 10.1186/cc5066. |
| 37488569 | Background | Nigatu AM, Yilma TM, Gezie LD, Gebrewold Y, Gullslett MK, Mengiste SA, Tilahun B. Medical imaging consultation practices and challenges at public hospitals in the Amhara regional state, Northwest Ethiopia: a descriptive phenomenological study. BMC Health Serv Res. 2023 Jul 24;23(1):787. doi: 10.1186/s12913-023-09652-9. |
| 18048893 | Background | Feiner JR, Severinghaus JW, Bickler PE. Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender. Anesth Analg. 2007 Dec;105(6 Suppl):S18-S23. doi: 10.1213/01.ane.0000285988.35174.d9. |
| 35816344 | Background | Gottlieb ER, Ziegler J, Morley K, Rush B, Celi LA. Assessment of Racial and Ethnic Differences in Oxygen Supplementation Among Patients in the Intensive Care Unit. JAMA Intern Med. 2022 Aug 1;182(8):849-858. doi: 10.1001/jamainternmed.2022.2587. |
| 35793817 | Background | Valbuena VSM, Seelye S, Sjoding MW, Valley TS, Dickson RP, Gay SE, Claar D, Prescott HC, Iwashyna TJ. Racial bias and reproducibility in pulse oximetry among medical and surgical inpatients in general care in the Veterans Health Administration 2013-19: multicenter, retrospective cohort study. BMJ. 2022 Jul 6;378:e069775. doi: 10.1136/bmj-2021-069775. |
| 2752811 | Background | Ries AL, Prewitt LM, Johnson JJ. Skin color and ear oximetry. Chest. 1989 Aug;96(2):287-90. doi: 10.1378/chest.96.2.287. |
| 34772785 | Background | Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12. |
| 36166259 | Background | Jamali H, Castillo LT, Morgan CC, Coult J, Muhammad JL, Osobamiro OO, Parsons EC, Adamson R. Racial Disparity in Oxygen Saturation Measurements by Pulse Oximetry: Evidence and Implications. Ann Am Thorac Soc. 2022 Dec;19(12):1951-1964. doi: 10.1513/AnnalsATS.202203-270CME. |
| 24435101 | Background | Braun T, Kunz U, Schulz C, Lieber A, Willy C. [Near-infrared spectroscopy for the detection of traumatic intracranial hemorrhage: Feasibility study in a German army field hospital in Afghanistan]. Unfallchirurg. 2015 Aug;118(8):693-700. doi: 10.1007/s00113-013-2549-0. German. |
| 29368021 | Background | Albutt K, Punchak M, Kayima P, Namanya DB, Anderson GA, Shrime MG. Access to Safe, Timely, and Affordable Surgical Care in Uganda: A Stratified Randomized Evaluation of Nationwide Public Sector Surgical Capacity and Core Surgical Indicators. World J Surg. 2018 Aug;42(8):2303-2313. doi: 10.1007/s00268-018-4485-1. |
| 31715537 | Background | Atumanya P, Sendagire C, Wabule A, Mukisa J, Ssemogerere L, Kwizera A, Agaba PK. Assessment of the current capacity of intensive care units in Uganda; A descriptive study. J Crit Care. 2020 Feb;55:95-99. doi: 10.1016/j.jcrc.2019.10.019. Epub 2019 Nov 4. |
| 32768344 | Background | Koltai DC, Dunn TW, Smith PJ, Sinha DD, Bobholz S, Kaddumukasa M, Kakooza-Mwesige A, Kajumba M, Smith CE, Kaddumukasa MN, Teuwen DE, Nakasujja N, Chakraborty P, Kolls BJ, Nakku J, Haglund MM, Fuller AT. Sociocultural determinants and patterns of healthcare utilization for epilepsy care in Uganda. Epilepsy Behav. 2021 Jan;114(Pt B):107304. doi: 10.1016/j.yebeh.2020.107304. Epub 2020 Aug 4. |
| 8870764 | Background | Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x. |
| 20568959 | Background | Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, Garza H, Maloney-Wilensky E, Plaum JM, Koenig CH, Johnson A, Morgan T. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010 Sep;27(9):1597-604. doi: 10.1089/neu.2010.1340. |
| Sample size calculator . Published online 2024. | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | InfraScanner 2500™ | All patients entered into the trial will undergo at least one cranial scanning using the InfraScanner 2500™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2500™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2500™. 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 2500™ are positive consideration of further follow-up will be given on a case-by-case basis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infrascanner 2500™ Diagnostic Performance | Number of participants with detection of intracranial hemorrhage (ICH) by the InfraScanner 2500™ stratified by CT Positive and CT Negative using the CT as the gold standard for ICH presence. | Number of participants with detection of intracranial hemorrhage (ICH) by the InfraScanner 2500™ stratified by CT Positive and CT Negative using the CT as the gold standard for ICH presence. | Posted | Count of Participants | Participants | Within 30 minutes following CT scan |
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| ||||||||||||||||||||||||||||||
| Secondary | Sensitivity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™ | The accuracy of the Infrascanner 2500™ reported through the sensitivity of intracranial hemorrhage (ICH) detection (as compared to CT findings). Sensitivity measures the ability to identify true positives. | Posted | Number | 95% Confidence Interval | percentage of true positives | Within 30 minutes following CT scan |
|
| |||||||||||||||||||||||||||||||
| Secondary | Specificity of Intracranial Hemorrhage (ICH) Detection by the Infrascanner 2500™ | The accuracy of the Infrascanner 2500™ reported through the specificity of intracranial hemorrhage (ICH) detection (as compared to CT findings). Specificity measures the ability to identify true negatives. | Posted | Number | 95% Confidence Interval | percentage of true negatives | Within 30 minutes following CT scan |
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|
Up to 30 minutes following CT scan
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InfraScanner 2500™ | All patients entered into the trial will undergo at least one cranial scanning using the InfraScanner 2500™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2500™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2500™. 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 2500™ are positive consideration of further follow-up will be given on a case-by-case basis. | 0 | 180 | 0 | 180 | 0 | 180 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Kolls, MD, PhD | Duke University | 9196812671 | kolls001@mc.duke.edu |
| Jan 22, 2026 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D016489 | Head Injuries, Closed |
| D020197 | Head Injuries, Penetrating |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D014950 | Wounds, Penetrating |
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| False Negative |
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