Page 60 - Journal of Special Operations Medicine - Fall 2016

Methods was simultaneously performed (echography 2: tourniquet
effectiveness). If the self-applied SOFTT-NH was efficient
This study and its protocol were approved by the insti- (i.e., with no flow), the volunteers did not continue the
tutional review board of Desgenettes Military Hospital protocol. If the SOFTT-NH application was ineffective or
in Lyon, France (approval No. 749/HIAD/MC, dated 3 insufficiently effective, either the CRoC or SJT was ran-
September 2014). domly applied over the right femoral pulse at the inguinal
region by one of four physician–nurse pairs, as a supple-
To compare the two devices, we conducted a clinical ment to the SOFTT-NH. A Doppler auscultation of the
study with healthy volunteers. The primary study end popliteal artery was simultaneously performed (echogra-
point was the effectiveness of CRoC or SJT for stopping phy 3: tourniquet and junctional tourniquet effectiveness).
hemorrhage at a junctional site (groin area), with effec- The time from initial junctional tourniquet application
tiveness defined as a complete interruption of the popli- until a nonmeasurable pulse occurred was recorded. Then
teal arterial flow, measured with Doppler auscultation, the SOFTT-NH was removed and the junctional tourni-
when self-applied tourniquets were ineffective to stop quet was tightened progressively. The effectiveness was
the distal arterial flow. The secondary study end points measured by Doppler auscultation (echography 4: junc-
were the effectiveness of CRoC or SJT used alone, the tional tourniquet effectiveness).
time to effectiveness, and subjective data evaluated by
Operators and volunteers. Finally, the junctional tourniquet was removed and a
questionnaire to evaluate the devices’ application was
Study volunteers belonged to the Medical Regiment of administered after each application by the pairs and the
La Valbonne in France; all were professional soldiers volunteer. The volunteers assessed the pain score on a
trained in combat casualty care. Exclusion criteria were scale from 1 to 5. The subjective time to effectiveness, the
any history of vascular illness, hypertension, heavy ease of use, the stability, and the effort required to achieve
smoking, venous thrombosis, an abnormal pretest Dop- hemorrhage control were all evaluated by the pairs on a
pler auscultation (echography 1: pretest), or any current scale from 1 to 5. Safety was defined as an absence of
illness. Each subject had a baseline evaluation of dis- adverse events, with the exception of uncomplicated pain
tal lower extremity pulse, heart rate, and systolic and that resolved promptly after device use. A time limit of 5
diastolic blood pressures. All the participants signed the minutes was used to reduce the compression time.
informed consent form.
The association between variables was investigated
The test assessors were four physician–nurse pairs using a statistical software (BiostaTGV; http://marne
trained to use the two devices. Junctional tourniquets .u707.jussieu.fr/biostatgv). Categorical variables were
were opened from packaging, assembled, and readied compared using the chi-square test and the Fisher test.
for use. To assess the degree of tightening for CRoC, Continuous variables were compared using the t test.
the height of the thread was measured in centimeters Significance for results was established at p < .05.
between the horizontal arm and the pressure disc. To
determine SJT efficiency, we counted the number of Results
times the pump was manually compressed. A tourniquet
®
SOFTT-NH (Tactical Medical Solutions; https://www Volunteers were 110 professional Soldiers from one
.tacmedsolutions.com) was self-applied before junctional Combat company. On the day of the data collection, 17
tourniquet application. were absent for professional reasons and six declined to
participate, thus leaving 87 volunteers to participate at
All echographic measurements were performed by a the study. Three subjects were excluded from the study:
single Operator who was an expert in ultrasound exam- two for medical reasons (inguinal hernia recent surgery
ination. The surrogate for efficiency was the absence of and recent distal vein thrombosis) and one for a techni-
any arterial flow detected by a handheld Doppler trans- cal reason (poor echogenicity). The remaining 84 sol-
ducer (Sonosite M-Turbo; Fujifilm Sonosite; https://www diers began the protocol.
.sonosite.com). Residual flow was considered as ineffec-
tive tourniquet application. After the use of the self-applied SOFTT-NH, 10 volun-
teers did not pursue the protocol because of the overall
After providing informed consent, each volunteer, wearing efficiency of the self-applied tourniquet. The remaining
French battle dress, performed a physical exercise (short 74 volunteers were then randomized into two groups:
running with heavy backpack) to approximate operational the CRoC group comprised 36 personnel and the SJT
context. Then, the volunteer self-applied the SOFTT-NH group comprised 38 personnel (Figure 1). This final
to the root of the thigh. Each subject chose the degree of group comprised 58 men and 16 women (aged 19–46
tightening. A Doppler auscultation of the popliteal artery years; average age: 28 years). The body mass index (BMI)

42 Journal of Special Operations Medicine Volume 15, Edition 3/Fall 2016