Tourniquet Training Effectiveness Study
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/30/2018 |
| Start Date: | April 4, 2018 |
| End Date: | July 15, 2018 |
Evaluation of Hemorrhage Control and Tourniquet Training Effectiveness for Laypersons
Trauma is the leading cause of death for individuals ages 1-45 years old, within this cohort,
and uncontrolled hemorrhage is the leading cause of preventable death.1,2 Tourniquets have
been shown to be effective in dramatically decreasing death from uncontrolled hemorrhage on
the battlefield and there is level 4 evidence that EMS application of tourniquets in the
civilian sector is effective though not to the same degree as in the military.3,4 Multiple
national groups have advocated that to further decrease preventable deaths from hemorrhage,
laypersons should apply tourniquets before the arrival of professional first responders. To
this aim, the "Stop the Bleed" campaign has trained over 100,000 individuals in the US in
hemorrhage control techniques and tourniquet use with the Bleeding Control Basic (B-Con)
course.5 The "Stop the Bleed" campaign informs course participants all commercial tourniquets
are equivalent, and improvised tourniquets should be applied if a commercial tourniquet is
not available.6 The investigators are evaluating the ability of the B-Con course participants
to apply three different types of commercial tourniquets, the Rapid Application tourniquet
(RAT), the Stretch-Wrap-And-Tuck tourniquet (SWAT-T), and the Sof Tourniquet (Sof-T) as well
as participants ability to fashion an improvised tourniquet. The investigators hypothesize
B-Con in its current form does not enable course participants to apply other commercial
tourniquets beyond the specific one taught, the CAT tourniquet, and does not teach how to
apply an improvised tourniquet.
and uncontrolled hemorrhage is the leading cause of preventable death.1,2 Tourniquets have
been shown to be effective in dramatically decreasing death from uncontrolled hemorrhage on
the battlefield and there is level 4 evidence that EMS application of tourniquets in the
civilian sector is effective though not to the same degree as in the military.3,4 Multiple
national groups have advocated that to further decrease preventable deaths from hemorrhage,
laypersons should apply tourniquets before the arrival of professional first responders. To
this aim, the "Stop the Bleed" campaign has trained over 100,000 individuals in the US in
hemorrhage control techniques and tourniquet use with the Bleeding Control Basic (B-Con)
course.5 The "Stop the Bleed" campaign informs course participants all commercial tourniquets
are equivalent, and improvised tourniquets should be applied if a commercial tourniquet is
not available.6 The investigators are evaluating the ability of the B-Con course participants
to apply three different types of commercial tourniquets, the Rapid Application tourniquet
(RAT), the Stretch-Wrap-And-Tuck tourniquet (SWAT-T), and the Sof Tourniquet (Sof-T) as well
as participants ability to fashion an improvised tourniquet. The investigators hypothesize
B-Con in its current form does not enable course participants to apply other commercial
tourniquets beyond the specific one taught, the CAT tourniquet, and does not teach how to
apply an improvised tourniquet.
Hemorrhage control by rapid application of commercial tourniquets has significantly improved
the survival of military personnel injured on the battlefield.7,8 The U.S. civilian
population has seen a spike in battlefield like injuries in the recent years, a prime example
being the Boston Marathon bombing.9,10 To address this issue, the American College of
Surgeons (ACS) formed a committee comprised of individuals from the fields of healthcare,
law-enforcement, fire department, pre-hospital care and the military. This committee came up
with a set of recommendation regarding first response and capacity building for hemorrhage
control, known as the Harford Consensus.11 These recommendations include educational programs
for lay-people in hemorrhage control with an emphasis on rapid and early tourniquet
application. There is level 4 evidence that after adjustment for covariates, emergency
medical providers' application of tourniquets in civilian trauma decreases mortality, though
not to the same dramatic degree seen in the military setting.12-14 Researchers are working to
show the effect of training of laypersons in hemorrhage control in the real world but no data
beyond the simulation setting is currently presented in the literature.15 Various groups have
developed training programs for hemorrhage control training, the most notable of which is the
ACS "Stop the Bleed" Bleeding Control Basic (B-Con) training.16 B-Con has trained over
100,000 individuals in the US since its implementation.5 Goralnick et. al. have shown that
there is moderate retention for the retention of B-Con specifically for application of the
Combat Application Tourniquet (CAT), which is also the type of tourniquet with the best
evidence for its use as it is the type used by the US military.17 However, the Hartford
consensus and the "Stop the Bleed" campaign state that "(1) commercial windlass-type
tourniquets should be used in the prehospital setting for the control of significant
extremity hemorrhage when direct pressure is ineffective or impractical, (2) improvised
tourniquets should be used only if no commercial device is available."5,18 This advocacy for
types of commercial tourniquets beyond the CAT and, more significantly, for improvised
tourniquets has not been studied in either a simulated or real setting.
There are multiple different tourniquet types available for which, while the principle is the
same for all, the actual mechanism and steps for application vary. B-Con in its current
iteration informs participants the principle is the same for both other commercial
tourniquets and improvised tourniquets, which is to be tight enough to occlude arterial
bleeding. Other courses which have been widely disseminated have taught how to use
tourniquets other than the CAT, such as the Stretch-Wrap-And-Tuck tourniquet (SWAT-T).19
Currently, the courses being offered typically only teach how to use one, and sometimes two,
different types of tourniquets. Furthermore, as there is not broad consensus statement about
which tourniquet type to use and teach, different groups distribute different types of
tourniquets in publicly available bleeding control kits, and professional first responders
carry different types of commercial tourniquets. A randomized trial has shown that among some
of the available commercial tourniquets, the CAT, ratcheting medical tourniquet (RMT), and
SWAT-T, the proportion of application for those without training ranges from 10.6-23.4%.
The B-Con course presumption that participants understand tourniquet principles rather than a
single technique, which would enable them to apply devices they have not seen before, has not
been evaluated. In this context, the investigators would evaluate participants, immediately
after completing the full B-Con course, on their ability to apply different commercial
tourniquets than what they were trained on and their ability to apply a commercial
tourniquet.
1. Study design:
a) Prospective open-label trial
2. Consent:
a) Verbal consent
3. Protocol:
1. All participants will receive the ACS stop the Bleed training from qualified
instructors. This training is 45 to 60 minutes long, consisting of an audio-visual
presentation with tourniquet application instructions followed by hands-on training
under the supervision of an instructor. The training takes place in groups of 20 to
50 at a time. The audio-visual part of the training takes place in groups of 20,
which are then divided in to subgroups of 4-8 for hands-on training with an
instructor. There is no compensation for the study participants.
2. The evaluation of hemorrhage control competence will take place individually. A
mannequin, the Hapmed tourniquet trainer, with a traumatic amputation of the leg
just above the knee will be present. A reviewer will provide instructions,
including that the lights on the leg represent continued bleeding and they will
have a maximum of 2 minutes to apply the tourniquet. The participant will be
provided a tourniquet and told to stop the simulated bleeding. Participants will be
tested in all 5 types of tourniquets sequentially using the same method but with
the order of testing varying according to the randomization. The reviewer will
start timing after telling the participant to begin. This will then be repeated for
the other type of tourniquet the individual will need to apply. No feedback will be
given to the participant throughout the testing process.
i) Supplies for the improvised tourniquet will include a T-shirt, long stretch of gauze,
a stick to act as a windlass, and a leather belt c) Parameters measured: i) The
participants will be timed until they feel that they have stopped the bleeding or they
tell the instructor they are done. The maximum amount of time provided to apply the
tourniquet will be 2 minutes based on the results of the investigators prior studies in
which the 90th percentile for time to correct application was 117 seconds.
ii) Appropriateness of hemorrhage control will be determined by correct placements of
tourniquet as defined by at least 2 inches proximal to the amputation site iii) Adequate
pressure to stop the bleeding which will be set at 250 mmHg. For unsuccessful hemorrhage
control, the reason for failure will be recorded.
iv) Correct tourniquet application defined by: (1) Time to application < 120 seconds (2)
Placement of tourniquet a minimum of 2 inches proximal to amputation (3) Tourniquet
application pressure > 250 mmHg d) All the reviewers would be physicians, nurses and
EMTs, trained in hemorrhage-control. The complete test for each individual will not take
more than 15 mins.
4. Randomization for the order of tourniquet application:
a) Permutated block randomization will be used to vary the order for application of the
5 different types of tourniquets (CAT, RAT, SWAT-T, Sof-T, and improvised tourniquet)
5. Pre-trial questionnaire:
a) Study subjects will be given a pre-trial questionnaire to gather information
regarding age, gender, and level of education. The questionnaire will also include
questions to assess their knowledge regarding hemorrhage control and to determine their
willingness and self-reported comfort level in acting as a first-responder in a mass
causality scenario. Answers will be presented on a Likert-type scale or dichotomous
yes-no.
6. Post-trial questionnaire:
a) After the hemorrhage control training, all participants will be given a questionnaire
to evaluate comfort level, self-efficacy, and other questions relating to hemorrhage
control response.
7. Sample size calculation:
1. Sample Size calculation was done for paired comparisons with 80% power and
Bonferroni corrected for 4 pairwise comparisons for an alpha level of 0.0125 and
correlation of 0.1. The largest difference was then taken as the sample size for
each arm.
2. The expected corrected proportions for the different tourniquets are:
1. CAT: 80-90% (Control)
2. RAT: 10-30%
3. SWAT-T: 10-30%
4. Sof-T: 20-40%
5. Improvised: < 10% ii) The smallest presumed difference in correct application
for the CAT (control) at 80% is to the Sof-T at 40%. To attain 80% power with
alpha of 0.0125 the required minimum sample size is 34.
3. All sample size calculations performed using Stata v14.1.
8. Statistical Analysis:
1. Paired statistical tests using McNemars test will be used for the univariate
analysis of the primary outcome of correct tourniquet application comparing the CAT
tourniquet as a control (CAT being type of tourniquet taught in the B-Con course)
to each of the other tourniquet types (RAT, SWAT-T, Sof-T, Improvised) for 4 total
pairwise comparisons.
2. Descriptive statistical analysis (ANOVA, Kruskal-wallis, Mann Whitney U test,
Student T-test) will be used to assess the secondary outcomes of time to tourniquet
application, estimated blood loss prior to tourniquet application, and pressure
applied by the tourniquet.
3. Multiple Logistic regression will be used to assess for predictors of correct
tourniquet application for each of the different tourniquet types. The model will
include age, gender, education level, any prior hemorrhage control training, and
success in application for each of the other tourniquet types.
4. Descriptive statistics will also be used to assess participants responses on the
questionnaires. Non-parametric statistical tests (Wilcoxon signed rank test and
generalized estimating equations) will be used to assess 5-point Likert scale
questions.
5. P-value for significance will be set at 0.05 after Bonferroni correction.
the survival of military personnel injured on the battlefield.7,8 The U.S. civilian
population has seen a spike in battlefield like injuries in the recent years, a prime example
being the Boston Marathon bombing.9,10 To address this issue, the American College of
Surgeons (ACS) formed a committee comprised of individuals from the fields of healthcare,
law-enforcement, fire department, pre-hospital care and the military. This committee came up
with a set of recommendation regarding first response and capacity building for hemorrhage
control, known as the Harford Consensus.11 These recommendations include educational programs
for lay-people in hemorrhage control with an emphasis on rapid and early tourniquet
application. There is level 4 evidence that after adjustment for covariates, emergency
medical providers' application of tourniquets in civilian trauma decreases mortality, though
not to the same dramatic degree seen in the military setting.12-14 Researchers are working to
show the effect of training of laypersons in hemorrhage control in the real world but no data
beyond the simulation setting is currently presented in the literature.15 Various groups have
developed training programs for hemorrhage control training, the most notable of which is the
ACS "Stop the Bleed" Bleeding Control Basic (B-Con) training.16 B-Con has trained over
100,000 individuals in the US since its implementation.5 Goralnick et. al. have shown that
there is moderate retention for the retention of B-Con specifically for application of the
Combat Application Tourniquet (CAT), which is also the type of tourniquet with the best
evidence for its use as it is the type used by the US military.17 However, the Hartford
consensus and the "Stop the Bleed" campaign state that "(1) commercial windlass-type
tourniquets should be used in the prehospital setting for the control of significant
extremity hemorrhage when direct pressure is ineffective or impractical, (2) improvised
tourniquets should be used only if no commercial device is available."5,18 This advocacy for
types of commercial tourniquets beyond the CAT and, more significantly, for improvised
tourniquets has not been studied in either a simulated or real setting.
There are multiple different tourniquet types available for which, while the principle is the
same for all, the actual mechanism and steps for application vary. B-Con in its current
iteration informs participants the principle is the same for both other commercial
tourniquets and improvised tourniquets, which is to be tight enough to occlude arterial
bleeding. Other courses which have been widely disseminated have taught how to use
tourniquets other than the CAT, such as the Stretch-Wrap-And-Tuck tourniquet (SWAT-T).19
Currently, the courses being offered typically only teach how to use one, and sometimes two,
different types of tourniquets. Furthermore, as there is not broad consensus statement about
which tourniquet type to use and teach, different groups distribute different types of
tourniquets in publicly available bleeding control kits, and professional first responders
carry different types of commercial tourniquets. A randomized trial has shown that among some
of the available commercial tourniquets, the CAT, ratcheting medical tourniquet (RMT), and
SWAT-T, the proportion of application for those without training ranges from 10.6-23.4%.
The B-Con course presumption that participants understand tourniquet principles rather than a
single technique, which would enable them to apply devices they have not seen before, has not
been evaluated. In this context, the investigators would evaluate participants, immediately
after completing the full B-Con course, on their ability to apply different commercial
tourniquets than what they were trained on and their ability to apply a commercial
tourniquet.
1. Study design:
a) Prospective open-label trial
2. Consent:
a) Verbal consent
3. Protocol:
1. All participants will receive the ACS stop the Bleed training from qualified
instructors. This training is 45 to 60 minutes long, consisting of an audio-visual
presentation with tourniquet application instructions followed by hands-on training
under the supervision of an instructor. The training takes place in groups of 20 to
50 at a time. The audio-visual part of the training takes place in groups of 20,
which are then divided in to subgroups of 4-8 for hands-on training with an
instructor. There is no compensation for the study participants.
2. The evaluation of hemorrhage control competence will take place individually. A
mannequin, the Hapmed tourniquet trainer, with a traumatic amputation of the leg
just above the knee will be present. A reviewer will provide instructions,
including that the lights on the leg represent continued bleeding and they will
have a maximum of 2 minutes to apply the tourniquet. The participant will be
provided a tourniquet and told to stop the simulated bleeding. Participants will be
tested in all 5 types of tourniquets sequentially using the same method but with
the order of testing varying according to the randomization. The reviewer will
start timing after telling the participant to begin. This will then be repeated for
the other type of tourniquet the individual will need to apply. No feedback will be
given to the participant throughout the testing process.
i) Supplies for the improvised tourniquet will include a T-shirt, long stretch of gauze,
a stick to act as a windlass, and a leather belt c) Parameters measured: i) The
participants will be timed until they feel that they have stopped the bleeding or they
tell the instructor they are done. The maximum amount of time provided to apply the
tourniquet will be 2 minutes based on the results of the investigators prior studies in
which the 90th percentile for time to correct application was 117 seconds.
ii) Appropriateness of hemorrhage control will be determined by correct placements of
tourniquet as defined by at least 2 inches proximal to the amputation site iii) Adequate
pressure to stop the bleeding which will be set at 250 mmHg. For unsuccessful hemorrhage
control, the reason for failure will be recorded.
iv) Correct tourniquet application defined by: (1) Time to application < 120 seconds (2)
Placement of tourniquet a minimum of 2 inches proximal to amputation (3) Tourniquet
application pressure > 250 mmHg d) All the reviewers would be physicians, nurses and
EMTs, trained in hemorrhage-control. The complete test for each individual will not take
more than 15 mins.
4. Randomization for the order of tourniquet application:
a) Permutated block randomization will be used to vary the order for application of the
5 different types of tourniquets (CAT, RAT, SWAT-T, Sof-T, and improvised tourniquet)
5. Pre-trial questionnaire:
a) Study subjects will be given a pre-trial questionnaire to gather information
regarding age, gender, and level of education. The questionnaire will also include
questions to assess their knowledge regarding hemorrhage control and to determine their
willingness and self-reported comfort level in acting as a first-responder in a mass
causality scenario. Answers will be presented on a Likert-type scale or dichotomous
yes-no.
6. Post-trial questionnaire:
a) After the hemorrhage control training, all participants will be given a questionnaire
to evaluate comfort level, self-efficacy, and other questions relating to hemorrhage
control response.
7. Sample size calculation:
1. Sample Size calculation was done for paired comparisons with 80% power and
Bonferroni corrected for 4 pairwise comparisons for an alpha level of 0.0125 and
correlation of 0.1. The largest difference was then taken as the sample size for
each arm.
2. The expected corrected proportions for the different tourniquets are:
1. CAT: 80-90% (Control)
2. RAT: 10-30%
3. SWAT-T: 10-30%
4. Sof-T: 20-40%
5. Improvised: < 10% ii) The smallest presumed difference in correct application
for the CAT (control) at 80% is to the Sof-T at 40%. To attain 80% power with
alpha of 0.0125 the required minimum sample size is 34.
3. All sample size calculations performed using Stata v14.1.
8. Statistical Analysis:
1. Paired statistical tests using McNemars test will be used for the univariate
analysis of the primary outcome of correct tourniquet application comparing the CAT
tourniquet as a control (CAT being type of tourniquet taught in the B-Con course)
to each of the other tourniquet types (RAT, SWAT-T, Sof-T, Improvised) for 4 total
pairwise comparisons.
2. Descriptive statistical analysis (ANOVA, Kruskal-wallis, Mann Whitney U test,
Student T-test) will be used to assess the secondary outcomes of time to tourniquet
application, estimated blood loss prior to tourniquet application, and pressure
applied by the tourniquet.
3. Multiple Logistic regression will be used to assess for predictors of correct
tourniquet application for each of the different tourniquet types. The model will
include age, gender, education level, any prior hemorrhage control training, and
success in application for each of the other tourniquet types.
4. Descriptive statistics will also be used to assess participants responses on the
questionnaires. Non-parametric statistical tests (Wilcoxon signed rank test and
generalized estimating equations) will be used to assess 5-point Likert scale
questions.
5. P-value for significance will be set at 0.05 after Bonferroni correction.
Inclusion Criteria:
- Participation in the Bleeding Control Basic Course
Exclusion Criteria:
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