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
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
Sponsor: Duke University

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
 
 
 
 
 
 
 
 
 
 
 
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 Mbarara Regional Referral Hospital 
 
Document Date: March 21, 2022 
 
NCT04505293 
 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
1. 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 Mbarara Regional Referral Hospital 
 
2. Study Team 
Principal Investigator:       
David Kitya, MBChB 
Co-Principal Investigator:  
Stephen Ttendo, MBChB 
Co-Principal Investigator:  
Anthony Fuller, MD, MScGH  
Co-Principal Investigator: 
Michael Haglund, MD, PhD, MACM 
 
3. Purpose of the Study: 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 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.  
 
Traumatic brain injury (TBI) is a global pandemic that affects over 10 million people 
annually, with the incidence expected to continue to proliferate in coming years (1). Severe 
TBI often results in intracranial hematoma formation that can rapidly increase intracranial 
pressure (ICP). If the bleeding does not tamponade, failure to alleviate the escalating pressure 
results in irreparable brain damage, and often death. In the case of an expanding intracranial 
bleed, a burr hole or decompressive craniotomy provide the only recourse to limit further 
brain injury and avert death. Typically, such decisions need to be made in hours, if not 
minutes, following the insult. In order to pursue such intervention, however, the presence of a 
surgically interveneable bleed must be confirmed, and moreover, the location of the bleed 
must be established.  
 
Typically, this is a trivial requirement, as CT scans are used ubiquitously to definitively 
diagnose EDH and SDH, readily and reliably triaging patients to surgical versus medical 
management. With 97% sensitivity, 98% specificity, 97% positive predicative value, 95% 
negative predictive value, and 96% accuracy in diagnosing intracranial hematomas, CT 
scanning is exquisitely effective at identifying or ruling out acute extra-axial, intracranial 
bleeds in patients who sustain head trauma, making it a gold standard in acutely assessing 
TBI (2). As a result, head CT has become commonplace, if not universal in assessing head 
trauma in industrialized countries, where virtually every hospital has one, if not a dozen 
scanners. In less than 10 minutes, a CT scan can noninvasively prove or reject acute 
intracranial bleeding. They provide immediate insight into 1.) Whether there is in fact an 
intracranial bleed; 2.)  In the case of a bleed, where below the cranium it has occurred and 3.) 
When done serially, gauge evolution, resolution, or stability of a bleed. This is invaluable 
information that directly impacts survival, as failure to perform a craniotomy in a patient 
with a rapidly expanding intracranial hematoma can swiftly lead to irreversible brain damage 
or even death. Moreover, performing such a surgery in the wrong location or in a patient who 
does not have a bleed amenable to surgical intervention can contribute extensive morbidity, 
exacerbating a patient’s already tenuous mortality.  

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
In less developed countries, CT scanners are often difficult to obtain in a timely manner. 
When they are present, they are extremely meager in number, peppered across treacherous 
geography, with scant transportation and emergency infrastructure. Even when accessible, 
they are frequently decommissioned due to a broken part, and are extremely cost prohibitive, 
with a single scan often costing the equivalent to multiple months’ income for the 
populations who need them most. As a consequence, in the settings where TBI pervades and 
brain imaging is most critical to survival, obtainment of such imaging is often unachievable.  
 
In resource-limited settings, techniques such as ultrasonic measurement of the optic nerve 
sheaths and latency of the pupillary reflex have been used to infer increased intracranial 
pressure. However, these techniques are notably crude. They provide no insight into the 
location or etiology of what is causing the presumed increase in pressure. Optic nerve 
ultrasound is typically positive only once ICP >30 mmHg (normal 7-15 mmHg), but is 
notably poor at correlatively quantifying ICPs as they grow emergently high. Optic nerve 
sheath diameter measurements take up to a day to manifest, long after irreparable brain 
damage has occurred. Hence, while these modalities can corroborate that a particular patient 
has increased ICP, these techniques are inadequate in determining which patients stand to 
benefit from surgery within a reasonable timeframe, and for those who do, in informing the 
surgical approach that could save such patient’s lives.  
 
In 1997, the first ever handheld device that could definitively detect the presence and 
location of epidural and subdural hematomas was introduced (3). Initially named the 
Runman, the device was intended to detect intracranial hematomas in remote and military 
settings to triage which casualties should be airlifted to medical centers equipped to offer 
neurosurgery. After numerous iterations, the InfraScanner 1000™ was introduced in the mid 
2000’s. In 2010, the pivotal five-site double-blinded clinical trail was published, and 
ultimately led to FDA clearance of the InfraScanner 1000™. In the study, the Infrascanner 
1000™ measurements were compared to CT scans of 365 patients, 96 of which were 
hematoma cases of various sizes, depths and locations. The study demonstrated high 
sensitivity (88%) in detecting hematomas > 3.5cc in volume and < 2.5 cm from the surface of 
the brain, and a specificity of 91%. Since then there have been numerous studies that have 
replicated these results and have substantiated that it is a capable tool for pre-hospital 
diagnosis of intracranial hematomas (3-13).  
 
While these results are extremely promising, the InfraScanner devices’ utility has only been 
examined through the lens of pre-hospital decision-making.  
 
A few years ago, the InfraScanner 2000™was introduced, prompting our group to validate it 
in a consecutive series of 500 head injury patients who obtained a head CT scan at Duke 
University Hospital (DUH). For all patients with CT-proven bleeds (n=104), irrespective of 
size, initial NIRD scans localized the bleed to the appropriate quadrant with a sensitivity of 
86% and specificity of 96% compared to CT scan. For extra-axial bleeds >3.5ml, sensitivity 
and specificity were 94% and 96%, respectively. For longitudinal serial rescans with the 
NIRD, sensitivity was 89% (<4 days from injury: sensitivity=99%) and specificity was 96%. 
For all patients who required craniectomy or craniotomy, the device demonstrated 100% 
sensitivity.  

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
With these results, the Duke Global Neurosurgery and Neurology (DGNN) proposes to 
initiate a trial to replicate our DUH findings at MRRH: using the Infrascanner 2000™ in the 
background of the current standard of care to quantify the accuracy of the device – the 
positive and negative predictive values – in diagnosing SDH/EDH relative to CT in the 
Ugandan setting.  
 
We hope that, with positive results, this work can lay the foundation for a subsequent trial 
using the device to diagnose intracranial bleeds when CT scans cannot be accessed in a 
timely manner. Such a result could ostensibly improve neurocritical and neurosurgical care in 
Uganda when obtainment of a CT scan is not feasible in a rapidly deteriorating patient.  
 
As the sensitivity and specificity in detecting traumatic intracranial hematomas approaches 
that of CT scanning, the prospect of using the InfraScanner 2000™ as a stand-alone 
diagnostic device for intracranial hematomas in low-resource settings that lack CT scans is 
highly intriguing. In geographical locations where TBI burden is highest and need for 
emergency craniotomies is most pressing, the inability to obtain CT scans precludes 
hundreds to thousands of life-saving surgeries everyday. The use of a handheld device that 
can be used repeatedly to reliably diagnose and track intracranial bleeding at no cost to a 
patient could revolutionize the prognosis of TBI for the majority of the 10 million people it 
affects annually.  
 
This project intends to show that the InfraScanner 2000™ is capable of detecting and ruling 
out intracranial hematomas in TBI patients at MRRH at rates similar to CT scan (i.e. 
replicate the results we have demonstrated at DUH in the Ugandan patient population). This 
work will hopefully justify initiation of a future trial using the InfraScanner 2000™ as a 
definitive diagnostic tool in determining surgical versus medical management in CT-barren 
settings, such as Uganda where our group, DGNN has been building neurosurgical and 
neurological care capacity over the past decade.  
 
Aim 1: 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.  
 
Aim 2: Use these findings to inform the feasibility of conducting a future trial in which the 
InfraScanner 2000™ is used as a stand-alone diagnostic tool for intracranial hematomas, and 
therein, to determine candidacy for decompressive craniotomies in patients who suffer TBIs 
in places where CT scans are not available. 
    
 
4. Background and Significance: Traumatic brain injury (TBI) is a steadily growing global 
pandemic responsible for immense mortality and morbidity, particularly in low- and middle-
income countries (LMICs). The World Health Organization (WHO) estimates that more than 
10 million people sustain TBI resulting in death or significant irreversible deficits annually, 
the majority occurring in resource scarce settings. Most recent approximations suggest that 
Sub-Saharan Africa (SSA) bears the highest incidence of road traffic injury (RTI)-associated 
TBI in the world. At a frequency of 170 per 100,000 people, TBI in SSA occurs at a rate 1.5 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
times that of the global average (1). A great preponderance of these injuries is comprised by 
intracranial hematomas; injuries that would often stand to benefit from surgical intervention. 
However, the virtual nonexistence of CT scanners in the majority of settings where these 
injuries occur, preclude countless patients from receiving life-saving surgery.  
 
With approximately 90% of all injury-related deaths occurring in LMICs, this already 
enormous chasm in mortality is expected to only grow wider as obtainability of personal 
motor vehicles burgeons at rates far exceeding these economically-stifled nations’ faculties 
to build legislatorial, municipal, and medical infrastructure capable of equipoising the 
mushrooming incidence of TBI.  
 
Sub-Saharan Africa’s unprecedented paucity of medical resources is especially prominent in 
neurological care. At present there are 0.3 neurological beds, 0.03 neurologists, and 0.01 
neurosurgeons per 100,000 Africans. This can be contrasted with Europe where, per 100,000 
citizens, there exist 17.1 neurological beds, 4.84 neurologists, and 2.43 neurosurgeons – a 
respective 57, 161, and 243-fold resource disparity between these two continents. Even when 
compared to global averages, to which Africa’s and myriad other LMICs contribute, per 
capita, the world’s population benefits from greater than 12-times more neurological beds, 
30-times more neurologists, and 56-times more neurosurgeons per capita than the average 
African (14).   
 
Taking Uganda, where our group, Duke Global Neurosurgery and Neurology, has worked for 
the past decade to bridge this gap, motorbikes pervade the landscape with motorbike 
accidents contributing the lion’s share of the country’s TBI. From a strictly commercial 
perspective, there are currently over 300,000 boda-bodas, or motorbike taxis, in Uganda’s 
capital city of Kampala – a comparable number to the total motorcycle registration in New 
York State, which has an area 750-fold larger than Kampala. Despite the highly visible 
mortality and introduction of a countrywide helmet law, helmet usage remains 31% and 1% 
among drivers and passengers, respectively. In Uganda alone, this leads to tens of thousands 
of deaths due to head injuries every year.  
 
Many of these lives could be saved with prompt imaging and surgical intervention; however, 
CT scans are far too expensive (for both the government as well as patient) to introduce on a 
national scale throughout Uganda or similarly resource-scarce settings. With myriad lives 
lost due to lack of access to prompt brain imaging, an economically feasible alternative to CT 
scan must be validated to begin saving these tens to hundreds of thousands of otherwise 
savable lives lost annually in LMICs.  
 
Based upon the scant literature regarding TBI within SSA, Uganda experiences among the 
highest rates of TBI and TBI-related mortality in the world. A recent study conducted in the 
intensive care unit (ICU) at Mbarara Regional Referral Hospital (MRRH), which serves the 
Western Region of Uganda, Rwanda, Eastern Democratic Republic of Congo, and 
northwestern Tanzania, revealed that head injury accounts for 74% of adult and 69% of 
pediatric trauma cases, with an overall mortality of 60% for patients admitted to the ICU with 
head trauma (15). For comparison, a 2006 UK study showed that in head injury patients 
requiring intensive care, 77% survived to leave the ICU and a 67% survived to leave 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
hospital, an ICU mortality rate nearly three-fold less than that seen in Mbarara (16). A 2014 
Finish study with a similar ICU survivability of 79%, reported an additional 12% mortality in 
the same population at 6-months(17). While no long-term TBI survivability data exists for 
LMICs, granted such significant post-discharge fatality in settings replete with vanguard 
healthcare resources and armed with robust long-term nursing and rehabilitative capacities, 
the ultimate survivability from severe TBI in SSA is presumably exceedingly rare. And at 
MRRH specifically, where in-patient mortality is unsurpassed and sub-acute convalescent 
services are nonexistent, this geographically vast TBI population assumes as bleak a fate as 
anywhere in the world.   
 
 
Despite the significant progress of the DGNN in helping to build neurosurgical capacity in 
Uganda, the diagnostic, non-operative, and critical care bandwidths for severely 
neurologically injured patients has remained lagged behind, with, as mentioned above, 
reported mortality outcomes at MRRH as high as anywhere in the world (15). While broaden 
access to neurosurgical care to the nation, the inability to readily diagnose intracranial 
bleeding in emergency situations has stifled the ability to furnish emergency neurosurgical 
care.  
 
 
With a median age of 15.7 years, Uganda is second only to Niger in youth of its population. 
Currently, 69% of the Ugandan population is under the age of 25, and an estimated 80% of 
all Ugandans between 20 and 30 years earn a living by taxiing passengers. Granted the 
already globally unprecedented motorbike usage, the cultural ambivalence toward helmets, 
haphazard law enforcement, and still increasing motorbike density, the already appalling 
incidence of TBI is inevitably going to upsurge in coming years.  
 
In Uganda, there are currently 33 ICU beds, 6 government neurosurgeons, and 1 formally 
trained neurologist to serve, not accounting for the significant international referrals received 
from neighboring countries, the entire population of 41 million people (18, 19). Despite the 
profound dearth of care and exceptionally high mortality, Africans pay significantly more out 
of pocket for medical care than the world (83% versus 26%), which in the case of current 
TBI care, often leads to incurrence of significant familial hardship for improbable survival 
(14). This constellation of unmatched mortality, resource famine, and debt incurrence fashion 
SSA, and MRRH in particular, the ideal setting to pilot a minimal-resource, guideline-driven 
ICU system. The InfraScanner 2000™ can potentially serve as the centerpiece of such a 
system providing near-zero-cost, immediately-available, sequential intracranial imaging to 
help make urgent surgical and medical decisions that can save an untold number of lives that 
are currently being forfeited due to lack of imaging.   
 
To work toward this, this study proposes to validate the high sensitivity, specificity, 
accuracy, and precision of the InfraScanner 2000™ in detecting traumatic intracranial bleeds 
we have previously demonstrated at DUH in patients presenting to MRRH. If able to detect 
intracranial hematomas with efficacy similar to CT in the Ugandan patient population, this 
data can be used to formulate a future trial using the device as a diagnostic tool to inform 
medicosurgical management for patients in which obtainment of CT scans is not feasible.   

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
 
5. Design, Procedures and methods: 
A prospective cohort study to be conducted at MRRH Division of Neurosurgery. Has 
emergency ward, the neurosurgery team is led by a Neurosurgeon, Emergency Medicine 
program with consultants, radiology department. When applicable (conscious patient and/or 
family or patient surrogate/attendant 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, using an IRB-approved 
verbal consent “script”, 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 obtain one to 
numerous measurements from each patient during his or her hospital stay. When subjects are 
approached for subsequent study measurements, if the participant has regained the capacity 
to consent or has a patient surrogate/attendant present, the verbal script will be used to obtain 
consent.  Participants will be asked at that time if prior measurements obtained may be used 
in the research. 
 
Upon presentation to the casualty unit at MRRH and/or within 30 minutes prior to  
each CT scan, the study team will approach the patient or the patient’s 
surrogate/attendant for permission to scan the patient’s cranium with the InfraScanner 
2000™ (Image A) and following the CT scan with the second Infrascanner (Image B). If 
permission is granted, the study team member will sequentially measure 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 twice should take <15 minutes. 
Should the patient obtain a subsequent CT scan(s) the number of scans the patient receives 
determines the number of potential data collections. The patient will be approached by the 
study team at the time of each CT scan and can decline participation during any individual 
encounter without withdrawing from the study.  
 
The collection period for each research participant concludes within 30-days following his or 
her initial consent, patient or patient surrogate/attendant decision to withdraw from further 
participation, hospital discharge, or patient death; whichever occurs first. 
 
 
 
6. Participant Recruitment and Compensation: Potential research participants will be 
approached by the research assistants. To avoid bias and potential coercion, the clinical team  
will not be involved in the participant recruitment. The research assistant will be graduate 
nurse. They will be trained in the consent process, and will make it abundantly clear that 
agreement or refusal to participate in the study will not influence the patient’s care in any 
way.  

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
  
7. Consent Process: After being made aware of the study by the research assistant and agreeing 
to hear more about the study, the prospective participant and/or the patient 
surrogate/attendant  will be given more information about the study. Upon admission to 
MRRH for suspected head trauma, the research assistant will introduce the patient or the 
patient’s patient surrogate/attendant to the presence of the study. If the consenting party 
agrees to hear about the study, The research assistant will greet the patient and will speak 
with patient and/or patient surrogate/attendant, thoroughly describing the protocol and reason 
for the study. All consenting study personnel will be trained in the consent process, and will 
provide ample reassurance to the patient or consenting party that the decision to participate 
will not, in any way, affect his/her medical care. Care will be taken to thoroughly answer all 
questions prior to obtaining final consent. The patient and/or patient surrogate/attendant will 
be clearly informed that the research protocol is completely optional, that participation will 
not affect the treatment they receive, and that, should they give consent, they are free to 
withdraw from the study at any time. They will be afforded indefinite time to make their 
decision to participate or withdraw from the study up unto: 1. 30 days following initial 
consent or 2. When they definitively will no longer receive brain CT scans / are discharged 
from medical care. The consent process will occur in the casualty unit at MRRH or at the CT 
scan of Mayanja Memorial hospital. The study team will be readily available to the patient, 
patient surrogate/attendant, and/or patient’s relatives throughout the study for any questions 
or concerns they may have.  
 
8. Data collection  
Once the participant is identified he will be assessed whether they met the inclusion 
criteria of the study. In they do, they will then be consented and and enrolled in the study.  
Data Collection will follow the follow chat below.  
 
 
All patients presenting 
with TBI
Screening 
•
Patients who present died
•
Patients with images other than Mayanja -
Memorial Hospital and Mbarara Regional 
Referral Hospital
• All those who don’t qualify for CT Scan image 
• All patients Below 12 years
• Patients who had a CT scan more than 30 
minutes ago 
Consenting 
CT Scan Image and Infrascanner Image, Demographic information  
Hospital Outcome or 30 days post consenting 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
 
 
 
 
 
 
 
  
9. Participant’s Capacity to Give Legally Effective Consent: We expect that most of the 
Participants will be neurologically and/or cognitively impaired due to extent of head injury, 
multisystem trauma, and/or medical treatments. Since this is a minimal risk study, we will 
offer study participation to subjects with diminished abilities if they have a patient 
surrogate/attendant. For patients with less severe injuries as well as those who are later into 
their hospitalization with resolving injuries, we expect a minority of subjects to be 
cognitively intact and capable of autonomously making decisions about their routine medical 
care. For such patients, they can consent without need for patient surrogate/attendant. The 
study will also be offered to patients 0 years of age and older. For patients younger than 18 
years, we will obtain assent from the participants, when he or she is cognitively able, and 
consent from their patient surrogate/attendantor parents. 
  
10. Study Interventions: As described above, upon arrival to the casualty unit and/or within 30 
minutes of each CT scan, the study team will scan the study participant’s cranium with the 
InfraScanner 2000™ (Image A). The study team member will use the device to sequentially 
emit light through fiberoptic light guides rested upon the patients scalp so that near-infrared 
light can be emitted in each of the quadrants (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 should take <10 
minutes. The number of CT scans the patient receives determines the number of potential 
data collections. The patient will be approached by the study team at the time of each CT 
scan and can decline participation during any individual encounter without withdrawing from 
the study.  
 
11.  Device Description/Mechanism: The following description is adapted from the 
InfraScanner White Paper (20): All biological tissue is, to differing extent, permeable to 
electromagnetic radiation of different frequencies and intensities. This can also be considered 
permeability to photons of different energy levels. This permeability to electromagnetic 
energy is the basis of all imaging based on transmission/scattering characteristics such x-ray, 
Computed Tomography (CT), and near-infrared, NIR, imaging. From the principles of 
spectroscopy, it is also known that different molecules absorb different wavelengths of 
electromagnetic radiation (which is synonymously referred to as light at shorter 
wavelengths). Similarly, tissue scatters radiation to different degrees. The Infrascanner is 
concerned with NIR imaging of the hemoglobin molecules. From any light source, photons 
follow a characteristic path through the target tissue back to a detector on the same 
approximate plane as the source. While the light is severely attenuated due to the scattering 
and absorption process, it is nonetheless encoded with the spectroscopic signatures of the 
molecules encountered en route to the detector (Image C).      

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
 
The principle used in identifying intracranial hematomas with the Infrascanner is that 
extravascular blood absorbs NIR light more than intravascular blood. This is because there is 
a greater (usually 10-fold) concentration of hemoglobin in an acute hematoma than in normal 
brain tissue where blood is contained within vessels. The Infrascanner compares left and 
right side of the brain in four different areas. The absorbance of NIR light is greater (and 
therefore the reflected light less) on the side of the brain containing a hematoma, than on the 
uninjured side. With specified wavelength ranges, optical light source(s) or emitter(s) and a 
photodetector are placed at a distance, which allows proper NIRS absorption measurements 
in a desired volume of tissue. The wavelength of 805nm is sensitive only to blood volume, 
not to oxygen saturation in the blood (Image D).    
 
The Infrascanner is placed successively in the left and right frontal (F), temporal (T), parietal 
(P), and occipital (O) areas of the head and the absorbance of light is recorded. Specifically, 
the placement is as follows: 
 
Frontal Left/Right forehead, above the frontal sinus; Temporal In the Left/Right temporal 
fossa; Parietal Above the Left/Right ear, midway between the ear and the midline of the 
skull; Occipital Behind the Left/Right ear, midway between the ear and the occipital 
protuberance (Image B). 
 
The difference in optical density (ΔOD) in each of the four symmetrical areas is calculated 
on a pair-wise basis from the following formula:  
 
 
where IN = the intensity of reflected light on the normal side, IH = the intensity of reflected 
light on the hematoma side.  
 
In summary: The Infrascanner includes three components: (1) the Scanner, (2) the 
Disposable Shield and (3) a Cradle. The Scanner includes a safe NIR diode laser and a 
silicon detector. The light to and from the laser and detector is optically coupled to the 
patient’s head through the disposable shield optical fibers. The optical fibers are long enough 
to reach through hair and contact the scalp. The optical fibers are placed 4 cm apart allowing 
optimal detection of hematomas. The extended fiber optics eliminates the need to shave off 
any hair. And because the fiber optic piece is disposable it prevents cross contamination. The 
detected light passes through an optical NIR band-pass filter in order to minimize 
background light interference. Electronic circuitry is included to control laser power and the 
detector signal amplifier gain. The detector signal is digitized and analyzed by a single board 
computer, SBC, in the Scanner. The SBC receives the data from the detector and 
automatically adjusts the settings of the Scanner to ensure good data quality. The data is 
further processed by the SBC and the results are displayed on the screen. Readout of the scan 
provides information on the severity of a hematoma and identifies the region of the brain 
bleeding. A higher optical density in the scanned region indicates a larger hematoma (20). 
 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
12. Risk/Benefit Assessment: There are neither any specific clinical benefits to the research 
participant, nor are there any direct incentives, financial or otherwise, provided to the 
research participant. There is no known health risk of interval, short-term. All data obtained 
with the Infrascanner 2000™ will be blinded from physicians participating in the care of 
study patients to avoid any deviation from standard of care.    
 
13. Costs to the Subject: No additional costs to the patient will be incurred as a result of this 
add-on research protocol. The participant will receive UGX 15000 as stipend for 
participating in the study.  
 
14. Statistical Considerations: Objectives: The primary objective of this study is to estimate the 
test characteristics (sensitivity, specificity, and the false positive and false negative rates) of 
the portable NIR-based device (InfraScanner 2000™) in the identification of any size 
hematoma among patients hospitalized at MRRH who have sustained or who are suspected 
to have sustained head trauma. For those who go on to obtain CT scans, the results of the CT 
scan(s) will serve as the gold standard. The sensitivity, specificity, and the false positive and 
false negative rates will be estimated at the patient level and at the scan level. Approximately 
10% of patients are anticipated to have more than one CT scan. 
 
A secondary objective is to estimate the 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. 
 
Exploratory objectives include: 
1. Examining the impact of factors such as hematoma type, location, and patient age 
on test characteristics of the InfraScanner 2000™ 
2. Determining the minimum resolution detectable by the InfraScanner 2000™ 
3. Analyzing the effects of extracranial hematomas, lacerations, and swelling on the 
performance characteristics of the device 
4. Estimating Receiver Operating Characteristic (ROC) curves with patient and scan 
as the units of analysis (20). 
  
Study Design: 
a) Eligibility:  All patiets with suspected TBI and meet the WHO and Brain Injury 
(BI) trust criteria for CT scaning  
Inclusion criteria 
Patients with suspected TBI above 12 years with suspected TBI and meet the BI 
criteria for CT scan 
Patients that present with CT that was taken within 30 minutes 
Patients with TBI that occurred more than 48 hours 
Patietns with suspected TBI who present to Mayanja Memorial Hospital for CT 
scan but managed at Mbarara Regional Referral Hospital  
Patients who do not present with CT scan images and cannot afford to pay for a 
CT Scan, will be included in the study and the study team will pay for their scans.  
 
Exclusion Criteria  

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
Patients who present died 
Patients with images other than Mayanja Memorial Hospital and Mbarara 
Regional Referral Hospital 
 
b) Standard of comparison: 
All patients entered into the trial will undergo at least one cranial scanning using 
the InfraScanner 2000™ at the time of presentation.  For patients who go on to 
get a CT scan, they will be scanned using the InfraScanner 2000™ within 30 
minutes of each subsequent CT. Patients and care providers will be blinded to the 
results of 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. For patients who never go on to obtain a CT scan, their InfraScanner 
2000™ results will be analyzed in the context of clinical data.  
 
 
Definitions of Sensitivity, Specificity, False Positive, False Negative: 
Let A+ denote the event that the test is positive for hematoma and B+ denote the 
event that a hematoma is present. Sensitivity, P(A+/B+), will be defined for each 
patient (scan) as the probability that a true hematoma as determined by CT scan 
will be detected (21).  Similarly, let A- denote the event that the test is negative 
for hematoma and B- denote the event that a hematoma is not present. Specificity, 
P(A-/B-), will be defined as the probability of being negative for hematoma on the 
InfraScanner 2000™ scan within 30 minutes of CT given the patient has no 
hematoma present.   
 
The false positive rate will be defined as PF+ = P(B-/A+) = P(A+/B-)[1-
P(B+)]/P(A+).  Similarly, the false negative rate will be defined as PF- = P(B+/A-) 
= [1-P(A+/B+)]P(B+)/[1-P(A+)].  Estimates for the false positive and false negative 
rates will be provided for a range of values for the prevalence of hematomas. 
 
c) Sample Size 
Computation of the required number of patients is based on estimating the 
sensitivity of each method to within at most +/- 0.10 with 90% confidence.  The 
90% confidence interval for the sensitivity is given by PSens +/- 1.645*SE(PSens) 
where SE(PSens)= [(PSens)(1- PSens)/N; N denotes the number of true positives.  
 
With 68 patients with positive findings of hematoma (i.e. CT-proven SDH/EDH) 
sensitivity can be estimated to within at most +/- 0.099 with 90% confidence.  
Assuming 20% of patients have true hematomas detected, 340 patients who obtain 
CT scans must be accrued (10).  We estimate that 50% of patients will obtain CT 
scans. Accounting for this, and allowing for a 5% dropout rate the required 
sample size for this trial is 720 total participants. With 272 patients having 
negative findings for hematoma via CT, specificity can be estimated to within at 
most +/- 0.05 with 90% confidence. 
 
d) Interim Analysis 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
An interim analysis will be conducted once 150 patients with accompanying CT 
scans have been enrolled in the study to estimate the prevalence of hematomas at 
MRRH. The adjusted 90% confidence interval estimate for sensitivity will also be 
constructed.  Based on these results the trial may be amended to enroll fewer or 
more patients. 
 
e) Accrual 
It is anticipated that at least 120 patients per month will be accrued and studied at 
MRRH. Study enrollment should thus be completed within approximately 6 
months. The collection period for each research participants concludes within 30-
days while in hospital  following his or her initial consent, patient or surrogate/ 
patient attendant  decision to withdraw from further participation, or hospital 
discharge, or patient death; whichever occurs first. 
 
15. Data and Safety Monitoring: Patients will be under continuous supervision during the 
entirety of each data collection period. Outside the ~10-minute window of each collection 
period, the patient is not subjected to any research intervention or influenced by the research 
in any way. As part of their treatment, patients will be under hospital care for their diagnoses 
for which they were admitted, and the research team will be in continual contact with the 
team regarding their clinical status and enrollment in the study. 
 
The PI will be responsible for securing and monitoring the data, including a quarterly review 
of data storage procedures. 
 
16. Privacy, Data Storage, and Confidentiality: Participants will be given as research 
numbers. Data will be stored on secured Qualtrics database and de-identified CT scans stored 
in a secure box folder. For analysis, data will be fully de-identified. Research materials will 
be stored in a locked cabinet in the Neurosurgery office in the Department of Neurosurgery 
and in digital form on the DHTS-maintained server.  
 
17. Limitation of study  
The study does not take into account those with brain swelling and contusions which may 
affect the outcome.  
 
18. Data Sharing Plan 
Data from this study will be shared equally by the principal investigators. We plan to publish 
to papers from this work. For the first paper first author will be a local investigator and will 
also be the corresponding author (Either Dr. Ttendo or Dr. Kitya). The author will be an 
international Investigator (Dr. Tony or Dr. Haglund), the same order will be followed for the 
last authors. The order will change for the second paper.  
 
 
 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
Image A (20) 
 
 
Image B (20) 
 
 
 
 
 
 
 

Infrascanner Study 
PI: Dr. David Kitya 
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Image C (20) 
 
 
Image D (20) 
 
 
 
 
 
 

Infrascanner Study 
PI: Dr. David Kitya 
Version 5: 21st March, 2022 
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