Poor short-term outcome in patients with ischaemic stroke.pdf
Bilateral NIR for traumatic vascular injury
1. Association for Academic Surgery
Bilateral near-infrared spectroscopy for detecting traumatic
vascular injury
Robert M. Van Haren, MD, Mark L. Ryan, MD, Chad M. Thorson, MD, MSPH,
Nicholas Namias, MD, MBA, FACS, Alan S. Livingstone, MD, FACS,
and Kenneth G. Proctor, PhD*
Dewitt-Daughtry Family Department of Surgery, University of Miami Miller School of Medicine, Ryder Trauma Center, Miami, Florida
a r t i c l e i n f o
Article history:
Received 2 January 2013
Received in revised form
14 March 2013
Accepted 27 March 2013
Available online 17 April 2013
Keywords:
Near-infrared spectroscopy
Vascular injury
Trauma
Battlefield
a b s t r a c t
Background: Extremity wounds account for most battlefield injuries. Clinical examination
may be unreliable by medics or first responders, and continuous assessment by experi-
enced practitioners may not be possible on the frontline or during transport. Near-infrared
spectroscopy (NIRS) provides continuous, noninvasive monitoring of tissue oxygen satu-
ration (StO2), but its use is limited by inter-patient and intra-patient variability. We tested
the hypothesis that bilateral NIRS partially addresses the variability problem and can
reliably identify vascular injury after extremity trauma.
Materials and methods: This prospective study consisted of 30 subjects: 20 trauma patients
with extremity injury and 10 healthy volunteers. Bilateral StO2 tissue sensors were placed
on the thenar eminence or medial plantar surface. Injured and non-injured extremities
within the same patient (DStO2) were compared using Wilcoxon signed ranks test. Receiver
operating characteristic curves were generated and areas under the curve (AUCs) were
calculated for DStO2 of 6, 10, and 15. Values are expressed as median (interquartile range).
Results: Trauma patients were age 31 y (23 y), 85% male, with injury severity score of 9 (5).
There were seven arterial and three venous injuries. Most involved the lower extremity
(n ¼ 16; 80%) and resulted from a penetrating mechanism (n ¼ 14; 70%). DStO2 between
limbs was 20.4 (10.4) versus 2.4 (3.0) (P < 0.001) for all patients with vascular injury versus
patients and volunteers with no vascular injury. DStO2 reliably identified any vascular
injury (AUC, 0.975; P < 0.001), whereas pulse examination alone or in combination with
Doppler exam could detect only arterial injury. A DStO2 of 6 had the greatest sensitivity and
specificity (AUC, 0.900; P < 0.001).
Conclusions: Continuous monitoring of bilateral limbs with NIRS detects changes in perfu-
sion resulting from arterial or venous injury and may offer advantages over serial manual
measurements of pulses or Doppler signals. This technique may be most relevant in
military and disaster scenarios or during transport, in which the ability to monitor limb
perfusion is difficult or experienced clinical judgment is unavailable.
ª 2013 Elsevier Inc. All rights reserved.
Presented at the Academic Surgical Congress, New Orleans, Louisiana, February 5, 2013.
* Corresponding author. Divisions of Trauma and Surgical Critical Care, Dewitt Daughtry Family Department of Surgery, University of
Miami Miller School of Medicine, Ryder Trauma Center, 1800 NW 10th Avenue, Miami, FL 33136. Tel.: þ1 305 585 1178; fax: þ1 305
326 7065.
E-mail address: kproctor@miami.edu (K.G. Proctor).
Available online at www.sciencedirect.com
journal homepage: www.JournalofSurgicalResearch.com
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 4 ( 2 0 1 3 ) 5 2 6 e5 3 2
0022-4804/$ e see front matter ª 2013 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.jss.2013.03.090
2. 1. Introduction
Throughout history, extremity wounds have accounted for
most combat injuries [1], and related vascular injuries have
high rates of morbidity and mortality [2e4]. Even with
increasing use of body armor in modern conflicts, this pattern
has continued because the thoracoabdominal region is pro-
tected, whereas the limbs remain exposed [5]. Extremity
wounds and vascular injury are also common in civilian
trauma centers [6]. Early detection of vascular injury and rapid
intervention is critical to prevent life-threatening hemorrhage
or the consequences of ischemia, which can lead to tissue
necrosis, compartment syndrome, and/or amputation [7,8].
Early detection of vascular injury is particularly challenging in
the austere battlefield environment or during pre-hospital
transport, when pulse examination may be unreliable and
conditions may prevent continuous assessment.
Near-infrared spectroscopy (NIRS) allows for continuous
noninvasive monitoring of tissue oxygen saturation (StO2)
within the microcirculation [9e11]. NIRS originally was used
in neurology and neurosurgery [12,13] and has been employed
in the diagnosis of subdural and epidural hematomas [14]. Its
ability to monitor cerebral oxygenation has also been applied
during operations such as carotid endarterectomy [15] and
those requiring cardiopulmonary bypass [16]. NIRS has also
been used to classify the severity of hemorrhagic shock
[17e19], guide fluid resuscitation in swine [20,21] and during
elective surgery [22], identify patients in septic shock [23,24],
and predict the development of multiple-organ dysfunction
syndrome [25,26].
Despite the promise of this technology, the clinical utility
of NIRS has been limited by large inter-patient and intra-
patient variability. Bilateral NIRS can potentially address the
inter-patient variability problem, but to our knowledge, has
not been evaluated for extremity vascular injury. The objec-
tive of this study was to test the hypothesis that bilateral
differences in StO2 detected by NIRS can reliably identify
vascular injury after extremity trauma.
2. Materials and methods
After obtaining institutional review board approval, a pro-
spective, nonrandomized, observational study was performed
in patients admitted to an urban Level I Trauma Center (Ryder
Trauma Center, Jackson Health System, University of Miami
Miller School of Medicine) with waiver of informed consent.
No medical decisions were made based on NIRS data.
From August 2009 to June 2012, a convenience sample from
all patients with an extremity injury was obtained. The study
population was composed of 30 subjects: 20 trauma patients
with extremity injury and 10 healthy volunteers. Bilateral
upper or lower extremity StO2 was measured using two
InSpectra Tissue Oxygenation Monitors (Model 650) and non-
sterile sensors (Model 1615; Hutchinson Technologies, Inc.,
Hutchinson, MN). Extremity StO2 measurements were ob-
tained from the thenar eminence or medial plantar eminence,
depending on injury location, for at least 10 min. Patients were
instrumented in the trauma resuscitation bay as their primary
and secondary survey was being completed, or in the oper-
ating room if emergency surgery was required. The healthy
volunteers were university employees and StO2 was measured
on bilateral upper extremities for 20 min.
NIRS data were downloaded using InSpectra StO2 Case
Graphing Software 3.2 (Hutchinson Technologies, Inc.).
Demographic data (age, sex, mechanism of injury, and injury
severity score [ISS]), clinical data (associated injuries, physical
examination findings, vital signs, laboratory values, diagnostic
imaging results, and operative repair details), and outcomes
(length of stay [LOS], intensive care unit [ICU] days, limb
salvage, and mortality) were also recorded. Doppler examina-
tion was performed with handheld continuous-wave probes.
Data were analyzed using PASW statistical software, version
17.0 (Chicago, IL). Comparisons were made between injured
and non-injured extremities within the same patient, (DStO2)
using the Wilcoxon signed ranks test. Values for sensitivity,
specificity, negative predictive value, and positive predictive
value were calculated for DStO2 and its ability to diagnose
vascular injury. Receiver operating characteristic (ROC) curves
were generated and areas under the curve (AUC) were calcu-
lated for DStO2 of 6, 10, and 15. Values are expressed as median
(interquartile range). Significance was assessed at P < 0.05.
3. Results
Patients with extremity trauma (n ¼ 20) were predominately
male (85%), with an age of 31 y (23 y) and an ISS of 9 (5). The
mechanism of injury was 70% penetrating; 80% involved the
lower extremity (Table 1). Patients arrived to the trauma
Table 1 e Demographics and injury characteristics.
Vascular
injury
(n ¼ 10)
No vascular
injury
(n ¼ 20)
P
Age 31 (12) 25 (9) 0.571
Sex (male) 90% 80% 0.640
Mechanism (penetrating) 80% 60% 0.628
Injury location (lower) 80% 40% 0.058
Extremity fracture 40% 70% 0.370
Intra-abdominal injury 20% 30% 1.0
Injury severity score 9 (7) 9 (4) 0.744
Admission data
Heart rate 109 (16) 93 (28) 0.142
Systolic blood pressure 115 (59) 142 (26) 0.210
Diastolic blood pressure 73 (33) 77 (27) 0.736
pH 7.39 (0.14) 7.39 (0.11) 0.935
Base deficit À2 (9) 0 (4) 0.119
Hemoglobin 11 (3) 13 (4) 0.105
Hematocrit 35 (9) 40 (16) 0.208
Outcomes
Limb salvage 90% 100% 0.474
Length of stay 21 (25) 6 (5) 0.247
ICU days 6 (14) 0 0.069
Mortality 0% 0% 1.0
NIRS data
DSt02 20.4 (10.4) 2.4 (3.0) <0.001
Recording time (min) 44 (43) 20 (5) 0.086
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 4 ( 2 0 1 3 ) 5 2 6 e5 3 2 527
3. center with a heart rate of 103 (29) beats per minute and with
systolic and diastolic blood pressures of 124 mm Hg (34 mm
Hg) and 77mm Hg (29 mm Hg).
Healthy volunteers were age 24 y (6 y) and 80% male. The
DStO2 for healthy volunteers and for trauma patients with no
vascular injury was not significantly different: 2.0 (1.9) versus
3.2 (3.5). These two groups were pooled to create a control
group to establish test sensitivity and specificity.
The median StO2 for the non-injured extremity (no
vascular injury and no trauma) was 88.1 (5.8) and 68.5 (27.8) for
thenar and plantar eminence, respectively. Comparable StO2
for healthy volunteers was 69.9 (21.3) and 70.4 (20.5) in the
right and left thenar eminence, respectively.
There were 10 patients who had extremity trauma with
a vascular injury (seven arterial and three venous) and 10 who
had extremity trauma without vascular injury. Most vascular
injuries occurred in the lower extremity (n ¼ 8; 80%). Six of
the vascular injuries (60%) had abnormal pulse exam (pulse
absent or weakly palpable). The four remaining vascular
injuries were taken to the operating room for the following
indications: hypotension (two venous injuries), computed
tomography (CT) angiogram with inconclusive findings (arte-
rial injury), and an open fracture washout (missed venous
injury). The arterial injuries involved two brachial arteries, two
superficial femoral arteries, two popliteal arteries, and one
unspecified. Five of the arterial injuries were transections and
two were vasospasm (Table 2). One resolved with papaverine
injection and the other resolved spontaneously. Specifically,
the venous injuries involved two femoral veins and one branch
of the femoral vein. Additional traumatic injuries included
a total of 11 extremity fractures (55%) and five solid organ
abdominal injuries (25%) requiring laparotomy.
Patients with vascular injury (n ¼ 10) were similar to those
with no vascular injury (n ¼ 20), in terms of demographics,
admission vital signs and laboratory values, and mortality
rate. Furthermore, there was no significant difference in NIRS
StO2 in patients with an extremity injury with or without
vascular injury (57.6 [46.3] versus 70.4 [8.8]; P ¼ 0.364) when
only data from a single probe were analyzed. The most likely
reason is that inherent differences in skin blood flow, adipose
tissue content, and other factors between patients masked the
effect of vascular injury. This analysis provides the rationale
for using bilateral probes.
Patients with vascular injury had a significantly greater
DStO2 between limbs compared with patients and volunteers
with no vascular injury: 20.4 (10.4) versus 2.4 (3.0) (P < 0.001).
Figure 1 shows patient data only (i.e., the volunteer group was
excluded). The graph shows that DStO2 between patients with
vascular injury versus no vascular injury remained signifi-
cantly different: 20.4 (10.4) versus 3.2 (3.5) (P ¼ 0.001).
In five arterial injuries (71%), StO2 was decreased in the
injured extremity versus the non-injured extremity. The
median DStO2 for all arterial injuries was 24.6 (11.4). All of
the venous injuries (n ¼ 3; 100%) had an increased StO2 in the
injured extremity compared with the non-injured extremity.
The median DStO2 for all venous injuries was 18.2 (5.8). NIRS
device output for representative cases of arterial and venous
injury are shown in Figures 2 and 3. The time of monitoring
was 20 min (38 min) for all subjects and 31 min (48 min) for
trauma patients.
Table2eDetailsofvascularinjuriesanddiagnosticmodalities.
LocationInjuryPulseexamDopplerexamSensorimotorexamHardsignsCTfindings
1BrachialarteryVasospasmAbsentNormalPulselessness
2SuperficialfemoralarteryTransectionAbsentNon-audibleNormalPulselessness
3PoplitealarteryTransectionWeakDecreasedsensory
andmotorfunction
NoneLossofflowatlevelofleftpopliteal
4PoplitealarteryVasospasmNormalTriphasicNormalNoneLossofflowwithadjacentbullet,
withdistalreconstitution.
Cannotruleoutvascularinjury.
5BrachialarteryTransectionWeakBiphasicDecreasedsensory
andmotorfunction
ParesthesiasandmildparalysisLossofflowatbrachialartery
6SuperficialfemoralarteryTransectionAbsentNormalPulselessness
7Unspecifiedarteryindistal
lowerextremity
TransectionAbsentNormalBleeding
8FemoralveinbranchTransectionNormalNormalNone
9FemoralveinTransectionNormalNormalBleeding
10FemoralveinTransectionNormalTriphasicDecreasedsensoryand
motorfunction
Bleedingandneurologicdeficits
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 4 ( 2 0 1 3 ) 5 2 6 e5 3 2528
4. The reliability of DStO2 for diagnosing vascular injury was
determined by constructing an ROC curve (AUC ¼ 0.975;
P < 0.001) (Fig. 4A). Table 3 lists the sensitivity, specificity,
and positive and negative predictive values of several DStO2
cutoffs to identify vascular injury. A DStO2 of 6 had the
greatest sensitivity and specificity, with an AUC of 0.900
(P < 0.001), which was superior to pulse examination alone or
in combination with Doppler exam. Figure 4B shows the ROC
curves for DStO2.
Ankle-brachial indexes (ABI) were either not performed or
not recorded in the medical records for these patients, but CT
angiogram was performed in four patients, three of whom had
vascular injuries. Operative repair included reverse saphe-
nous vein graft and synthetic polytetrafluoroethylene grafts
for arterial injuries and suture ligation for venous injuries.
There were no mortalities in the study population.
The total hospital length of stay was 7 d (19 d), with 0 ICU days
(9 ICU days). There were no differences in LOS, ICU days,
and mortality rates between patients with or without a vas-
cular injury. The limb salvage rate was 95%, with one lower
extremity limb loss.
The only patient to lose a limb underwent an above-knee
amputation after failure of popliteal artery transposition
with polytetrafluoroethylene. In this case, the leg became
a source of septic shock that required urgent amputation.
On presentation the mangled extremity score [27] was 6; the
patient also had motor and sensory loss in the extremity. Limb
salvage was attempted because of his young age, hemody-
namic stability, and short ischemic time (< 1 h).
4. Discussion
To our knowledge, this is the first report showing that bilateral
NIRS can reliably detect differences in StO2 caused by ext-
remity vascular injury. DStO2 reliably identified vascular
injury (AUC, 0.975; P < 0.001), whereas pulse examination
alone or in combination with Doppler exam could detect only
arterial injury. Thus, the sensitivity and specificity of NIRS for
diagnosing vascular injury was greater than pulse examina-
tion alone or in combination with Doppler exam.
NIRS has two advantages for diagnosing vascular
injury compared with conventional clinical tools. It provides
continuous, noninvasive trends in perfusion, rather than
an intermittent measurement (such as pulse and Doppler
examination). It is also easy to use and the results are
straightforward to interpret for persons with minimal
training. Most important, NIRS was able to diagnose vascular
injury at least as reliably as conventional clinical tools, which
typically require a skilled practitioner. DStO2 of 6, 10, and 15
were all significant predictors of vascular injury. However,
DStO2 of 6 had the largest AUC and had the best cutoff for
diagnosing vascular injury because it minimized false posi-
tives and false negatives. The low sensitivities and specific-
ities of pulse examination alone or in combination with
Doppler exam is likely because three of the vascular injuries
were venous and would normally be missed by pulse or
Doppler examination.
Hundreds of studies show the potential of NIRS to estimate
global tissue perfusion or perfusion in a specific anatomic
region. It has been used to diagnose compartment syndrome
in trauma animal models [28] and patients [29,30]. Giannotti
et al. [29] demonstrated that StO2 increases after fasciotomy in
patients with compartment syndrome. Most investigators
consistently report the reliability of trend data within the
same patient. Beekley et al. [31] obtained StO2 on United States
combat casualties in Iraq. An NIRS sensor was applied to the
thenar eminence; if it was not available, the deltoid was used,
followed by the anterior thigh. Arrival StO2 predicted the need
for blood transfusion in hemodynamically stable soldiers
(systolic blood pressure > 90 mm Hg) and may be useful as
a triage tool in far-forward settings. Despite these findings, it
is not known whether NIRS is a research device or a clinically
useful tool, because of the large inter-patient and intra-
patient variability. Several investigators have observed large
differences between adjacent tissues in the same patient;
others have observed higher thenar values in patients in
Fig. 1 e Median DStO2 in extremity of trauma patients with
or without vascular injury. **P < 0.001.
Fig. 2 e Near-infrared spectroscopy output displays
decreased StO2 in extremity with arterial injury.
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 4 ( 2 0 1 3 ) 5 2 6 e5 3 2 529
5. shock versus normal controls. Bilateral probes solve this
problem because each measurement site has its own control.
The algorithm for the diagnosis of extremity vascular
injury is well established [32]. Hemorrhage from an injured
extremity should be managed during the circulation phase
of the primary survey and can be diagnosed by diminished
or absent pulses or diminished or absent Doppler signals. If
secondary survey reveals a hard sign of arterial injury, emer-
gent operation is required. Hard signs include external
bleeding, rapidly expanding hematoma, any classic signs of
arterial occlusion (pulselessness, pallor, paresthesias, pain, or
paralysis), and a palpable thrill or audible bruit [33]. However,
there are many situations in which the diagnosis of vascular
injury is more complicated. Patients with a venous injury and/
or soft signs of arterial injury (history of arterial bleeding at
the scene or in transit, proximity of a penetrating wound or
blunt injury to an artery, small nonpulsatile hematoma over
an artery, and a neurologic deficit originating in a nerve
Fig. 3 e Near-infrared spectroscopy output displays increased StO2 in extremity with venous injury.
Fig. 4 e (A) Receiver-operating characteristic curve for StO2 ability to diagnose vascular injury. (B) Receiver-operating
characteristic curves for DStO2 ability to diagnose vascular injury. (Color version of figure is available online.)
j o u r n a l o f s u r g i c a l r e s e a r c h 1 8 4 ( 2 0 1 3 ) 5 2 6 e5 3 2530
6. adjacent to a named artery [33]) require further investigation
such as ABI, brachial-brachial index, or arterial pressure index
[34,35]. Additional workup such as duplex ultrasonography,
CT angiography, or angiography is sometimes needed to
establish diagnosis of vascular injury [35e38].
This study demonstrates proof of a concept that bilateral
NIRS can detect vascular injury; however, this method is
unlikely to replace experienced clinical judgment. NIRS might
be useful in the civilian trauma center as a trend monitor to
follow changes between serial physical examinations, but in
general it would have limited application in a resource-rich
environment. On the other hand, bilateral NIRS could be
used by battlefield medics on the frontline to identify vascular
injury. NIRS would be useful if experienced clinical judgment
is not available, such as during mass causality events in
military or civilian settings.
Major limitations of this study include the relatively small
nonconsecutive convenience sample and the fact that no
medical decisions were based on the results. Most patients
were relatively young and hemodynamically stable. Changes
in StO2 may be difficult to interpret in patients in shock, or in
an elderly population where differences may reflect chronic
peripheral vascular disease rather than vascular trauma. It is
conceivable that pulse and/or Doppler exams would be
equally unreliable under these conditions. Patients with
trauma to bilateral extremities could not be evaluated with
this method. The size and portability of the monitoring
system may become problematic when attempting to apply
this technology in austere environments. Our study required
two monitors for bilateral measurements, but other manu-
facturers have multi-channel monitors (Somanetics INVOS,
Troy, MI: and Nonin Model 7600 Regional Oximeter, Plymouth,
MN). In addition, healthy volunteers had upper extremities
measured; however, most trauma patients had injury and
measurement to lower extremities.
This small study in a select group of trauma patients
demonstrates proof of concept; bilateral NIRS has the
potential to detect changes in limb perfusion resulting from
arterial or venous injury. This technology likely does not
provide an advantage in the diagnosis of arterial injury,
which can reliably be diagnosed with clinical examination
and/or ABI. However, the ability of NIRS to diagnose venous
injury is important, because these injuries are not found
with pulse examination. This is probably more relevant to
military and disaster scenarios, in which the capability to
monitor limb perfusion is difficult and experienced clinical
judgment is unavailable. This technique might be a useful
adjunct as a trend monitor for vascular injury in the
civilian setting.
Acknowledgment
Supported in part by grants N140610670 from the Office of
Naval Research and 09078015 from the United States Army
Medical Research and Materiel Command. The authors thank
Matthew E. Spagnoli of Hutchinson Technologies, Inc., for
providing the InSpectra StO2 Tissue Oxygenation Monitors
and disposable sensors.
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