Next Generation Tourniquet Recommendations For.596

Journal of Trauma and Acute Care Surgery, Publish Ahead of Print
DOI: 10.1097/TA.0000000000004237
Next Generation Tourniquet: Recommendations for Future Capabilities and

Downloaded from http://journals.lww.com/jtrauma by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX
Design Requirements
1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 02/19/2024
Sena R. Veazey, MS1 (sena.r.veazey.ctr@mail.mil, ORCID 0000-0001-9195-0850)
D
Jared F. Mike, PhD1 (jared.f.mike.ctr@mail.mil)
Darke R. Hull1,2 (hulldar@oregonstate.edu)
TE
Kathy L. Ryan, PhD1 (Kathy.l.ryan.ctr@mail.mil)
Jose Salinas, PhD1 (jose.salinas4.civ@mail.mil)
John F. Kragh, Jr, MD1 (john.f.kragh.civ@mail.mil)

EP
1
U.S. Army Institute of Surgical Research, U.S. Army Medical Research and Development
Command, San Antonio TX

2
Oregon State University College of Engineering, 101 Covell Hall, 1691 SW Campus Way,
C
Corvallis, OR 97331
C
Correspondence: Sena Veazey, MS
US Army Institute of Surgical Research

A
3698 Chambers Pass
JBSA Fort Sam Houston, Texas 78234
sena.r.veazey.ctr@mail.mil; 210-539-4667
1
Conflicts of interest: None to declare. All JTACS Disclosure forms have been supplied and are
provided as supplemental digital content (http://links.lww.com/TA/D505).

Author Contribution: SV, JM, DH, JK, and KR developed the study design; SV, JM, DH
conducted the study and primary data analyses; SV, JM, DH drafted the initial manuscript; SV,
JM, DH, JK, KR, JS provided key revisions and final edits.
D
Funding: 1. JPC6 Combat Casualty Research Program W81XWH-21-CCCRP-AD
TE
2. Oak Ridge Institute for Science and Education
Acknowledgements: We wish to thank all our panelists involved in the survey and working
EP
group meetings. We appreciate their time, expertise, and involvement that was crucial for the
results of this research study.
Disclaimer: The views expressed in this article are those of the authors and do not reflect the
C
official policy or position of the U.S. Army Medical Department, Department of the Army, DoD,
C
or the U.S. Government.

A
Social Media Information:
Media Summary: Consensus on future development of next generation #tourniquets to guide new
development of devices to address #prolongedcasualtycare needs. Forging the next wave of
tourniquets to #stopthebleed.
Social media handles: Twitter @usa_isr
2
This is an open-access article distributed under the terms of the Creative Commons Attribution-
Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to
download and share the work provided it is properly cited. The work cannot be changed in any
way or used commercially without permission from the journal.

D
TE
EP
C
C
A
3
Abstract
Background: Advances in tourniquet development must meet new military needs for future
large scale combat operations or civilian mass casualty scenarios. This includes the potential use
of engineering and automation technologies to provide advanced tourniquet features. A

comprehensive set of design capabilities and requirements for an intelligent or smart tourniquet
needed to meet the challenges currently does not exist. The goal of this project was to identify
D
key features and capabilities that should be considered for the development of next generation
tourniquets.
TE
Methods: We used a modified Delphi consensus technique to survey a panel of 34 tourniquet
subject matter experts to rate various statements and potential design characteristics relevant to
tourniquets systems and their use scenarios. Three iterative rounds of surveys were held,
EP
followed by virtual working group meetings, to determine importance or agreement with any
given statement. We used a tiered consensus system to determine final agreement over key
features that were viewed as important or unimportant features or capabilities. This information
was used to refine and clarify the necessary tourniquet design features and adjust questions for
C
the following surveys.

C
Results: Key features and capabilities of various were agreed upon by the panelists when
consensus was reached. Some tourniquet features that were agreed upon included but are not
A
limited to: Capable of being used longer than 2 hours, applied and monitored by anyone, data
displays, semi-automated capabilities with inherent overrides, automated monitoring with
notifications and alerts, and provide recommended actions.
Conclusions: We were able to identify key tourniquet features that will be important for future
device development. These consensus results can guide future inventors, researchers, and
4
manufacturers to develop a portfolio of next generation tourniquets for enhancing the capabilities
of a prehospital medical provider.
Study Type: Survey

Level of Evidence: 5
Keywords: tourniquets, requirements, consensus, survey
D
TE
EP
C
C
A
5
Background
Tourniquets are lifesaving tools to stop bleeding from limb wounds and have been used
in ancient and modern day wartimes.(1-3) Today’s tourniquets were originally developed for the
military but are now widely used by civilians, and have features such as being durable,
inexpensive, and able to be self-applied (one-handed) by the casualty(4). However, the basic
design of these portable devices has been largely unchanged. Although current tourniquet
D
capabilities have been adequate for past conflicts(5), the ever changing climate in war and
civilian mass casualty (MASCAL) scenarios may require addition of new features and
TE
capabilities for tourniquet design. Although new tourniquet designs have been suggested, they
have not been widely adopted(6, 7). In the military setting of Large Scale Combat Operations
(LSCO)(8) and prolonged casualty care (PCC), trauma casualties must be managed at or near the
EP
point of injury for extended periods of time(9-12). There are parallels to LSCO/PCC in civilian
situations in which delayed evacuations and limited resources may occur, such as wilderness
medicine or MASCAL scenarios(13, 14). Civilian pre-hospital settings also benefit from
tourniquet usage, where examples include penetrating trauma from firearms and stabbings, care
C
under fire for police officers, terrorist attacks, rural incidents where transportation to definitive
C
care is delayed, and industrial accidents(15). Therefore, there is a need for medical devices to
enhance medical provider capabilities beyond typical standard of care. Tourniquets may need to
A
be reevaluated to account for prolonged use, management of multiple casualties, relevant data
for patient monitoring, and training requirements(16). Development efforts should focus on
enhanced capabilities to alleviate caregiver (both manual and cognitive) burden while continuing
to provide effective hemorrhage control. Tourniquet traits are expected to change to suit LSCO
needs, but those traits that suit such needs have not yet been identified.
6
Future enhanced tourniquets present new possibilities for automated capabilities that are
more intuitive, more instructive, and promote proper placement and use. To determine the
capabilities needed for these smart tourniquets, we employed a modified Delphi survey
methodology to establish a consensus, an agreement among a set of tourniquet subject matter
experts (SME) panelists, to define what these capabilities should be(17-20). The Delphi Method
D
is a framework for implementing qualitative research studies to determine consensus, or lack
thereof, among a wide breadth of SMEs(19, 21). It is implemented through anonymous surveys
TE
issued to isolated respondents. This survey process is repeated until the results stabilize. Notably,
the method is traditionally terminated when stabilization is reached, rather than consensus; it is
terminated when the responses are consistent (i.e., steady state) rather than in agreement among
EP
individual responders(20, 22).
We used this methodology to capture which tourniquet features are important when
C
considering implementation of new technologies for future smart tourniquet design and
development work. Specifically, our objectives were to determine potential tourniquet features
C
and recommendations based on various use-case scenarios that were determined by the SMEs
A
and which of those features were the most critical in the operational environment as well as for
civilian sectors. We explicitly chose the Delphi method to address these objectives to develop a
group consensus to prioritize which features were consistently recommended. Our studies were
deliberately designed to facilitate exchange of information throughout regular working groups
and surveys with additional comments.
7
Methods:
Regulatory Approval and Standards

This research study was conducted under protocol (# H-21-029nh) approved by the Research
Regulatory Compliance Division. This study conforms with the CREDES guideline and a
complete checklist has been uploaded as Supplemental Digital Content (Supplemental Digital
D
Content, Table 1, http://links.lww.com/TA/D504).
TE
Panel Selection
We first curated a list of potential panelists based on each panelist’s current or prior tourniquet
experience in research, development, clinical use, or manufacturing based on our network of

EP
previous and/or current known individuals from our research team. Potential panelists came
from various sectors including operational military, military research, patient care, and
manufacturing companies. We sought a heterogeneous group to represent broad experiences

C
supporting the end user of a smart tourniquet. Panel participation was voluntary, and panelists
were not reimbursed for their time. Each potential panelist was contacted via email and given the
C
option to participate. Additionally, we allowed panel participants to recommend other potential

A
panelists who met the tourniquet experience criterion. The panel included medics, paramedics,
nurses, engineers, physicians (emergency, surgeon, trauma), instructors, veterinarian, and
scientists (health, microbiology, engineering) from industry, academia, and military. Panelists
represented the US, Canada, Belgium, and Israel.
8
Study Design
Time was allotted for up to four working group meetings and surveys over the course of five
months. However, consensus was achieved by the third survey, and a fourth working group
meeting and survey were not needed to complete the study.
D
Our first survey round consisted of 17 broad topic statements associated with tourniquet use,
function, and product development. A total of 34 panelists participated. Each panelist was given
TE
an anonymized survey via email and was asked to assign a score from 1 (least important) to 10
(most important) to each topic statement. A working group meeting was then conducted to
discuss the results and to determine which statements should be further investigated or dropped.
EP
(Figure 1).
The second survey was based in part on the numerical responses and comments to the first
C
survey, with additional questions based on discussion points from the working group meeting.
The round 2 survey consisted of two sections. The first section consisted of 7 statements that
C
were rewritten based on statements from Round 1 that had high agreement and were used for
A
gauging inter-reliability among the panelists. Each statement was rated independently from a
scale of 1 to 7, with 1 being highly disagree and 7 being highly agree. The second section of
survey 2 consisted of 10 questions with various statements for each question, and respondents
ranked each statement dependently to determine ordinal ranking. A second working group
meeting was then conducted to discuss the results.
9
The third survey was constructed to refine each tourniquet feature and to determine exact end-
user capabilities that were most or least important. The round 3 survey consisted of 12 questions
in 4 broad topic areas (Data Collection and Transfer, Alarms and Alerts, Decision Support, and
Tourniquet Usage) with varying statements for each question rated on a 9-point Likert scale with
1-3 being not important, 4-6 being important but not critical, and 7-9 being very important and
D
critical. Optional sections were available for the panelists to write in comments.
TE
Analysis and Criteria for Consensus
The median score of each survey statement among all respondents was used to evaluate the
statement’s overall importance. When medians were equal, summations of each panelists’ points
EP
were analyzed to differentiate which statement ranked higher. Consensus was calculated by
determining how many panelists scored similarly for that particular statement. Similar scores
were 1-3 for not important, 4-6 for neutral, and 7-9 (or 10) for very important. The consensus
C
was met if at least 50% of the panelists gave a score within those ranges. We determined a tiered
consensus concept in which: 1) ≥50% and <60% were defined as “Minimum consensus”; 2)
C
≥60% and <70%, as “Moderate consensus”; and 3) >70-100%, as “High consensus”. For
A
example, if 17 out of 34 panelists (i.e., 50% of panelists) rated a statement as “highly important”
(i.e., statement score of 7, 8, or 9), it would meet a “Minimum consensus” that the statement was
highly important.
10
Results:
The demographic breakdown of panelists is presented in Supplemental Digital Content, Table 2,

http://links.lww.com/TA/D504. The panelists predominantly consisted of those affiliated with
government/military institutions (76%), with the remaining panelists from industry (15%),
academia (6%), and one “other” (3%). The distribution of the panelists’ listed range of years of
D
tourniquet experience (Supplemental Digital Content, Figure 1, http://links.lww.com/TA/D504)
and their listed expertise level (Supplemental Digital Content, Figure 2,
TE
http://links.lww.com/TA/D504) in each round shows that the majority of the panelists have 15+
more years of experience and identifying as intermediate or experts with tourniquets. Although
drop-outs occurred after each subsequent survey round, the agency representation percentages
EP
remained constant throughout the rounds. Expertise in tourniquet use by panelists was self-
reported and varied (47% expert to 17.6% novice).

C
Survey 1 Results
Survey 1 served as a baseline for the evaluation of tourniquet capabilities. The median scores and
C
consensus of statements’ importance are presented in Supplemental Digital Content, Table 3,
http://links.lww.com/TA/D504. Consensus was achieved for 12 total statements (7 High, 3

A
Moderate, and 2 Minimum consensus). High consensus was achieved for the high importance of
semi-automated deflation, data transfer, use >2 hours, weight, materials, environment, and one-
handed usability. Highlights of the first working group meeting included: 1) general agreement
that tourniquets integrated into uniforms were not desired; 2) elimination of factors that were
11
considered too dependent on manufacturing (costs, weight, materials); and 3) clarification of the
device end user (i.e., a prehospital medic).

Survey 2 Results
A total of 25 panelists completed Survey 2. The median ranks, level of agreement (Section 1) or
D
importance (Section 2), and consensus levels for both sections of Survey 2 are presented in
Supplemental Digital Content, Table 4, http://links.lww.com/TA/D504. In Section 1, at least
TE
Minimum consensus was achieved for all seven statements, whether agreement or disagreement.
High consensus was achieved for high agreement with statements concerning use greater than 2
hours and tourniquet use in critical scenarios such as MASCAL, care under fire (CUF), etc.
EP
Section 2 consisted of 10 questions with consensus around limb loss and the effects of release
being important considerations in use longer than 2 hours. For unacceptable outcomes for a
C
smart tourniquet with self-inflation features, there was moderate consensus that failure to
activate and inappropriate or premature deactivation were most important, and High consensus
C
that increased cost from automated systems was least important.

A
Furthermore, during the working group discussions, it was clear that questions of engineering
solutions (e.g., questions 2C, 2D, 2E, 2F, and 2G) unnecessarily constrain future development
and these lines of inquiry were discontinued, leaving room for future innovation.
12
Survey 3 Results
Sixteen panelists completed Survey 3. Four broad topic areas were covered (Supplemental
Digital Content, Table 5, http://links.lww.com/TA/D504).

Data Collection and Transfer. Concerning data relevant to tourniquet use (Q1) and role of care
transfer (Q2), there was High consensus that “time since application” (i.e., duration of use) was
D
very important and critical. Questions posed about data transfer from tourniquet to its user (Q3)
and from tourniquet to the next provider (Q4) achieved similar consensus results to each other:
TE
There was High consensus that written information was very important and critical.
Alarms and Alerts. There was consensus around various ways that alarms and alerts should be
EP
displayed including on a screen (Q6). It was also determined to be very important and critical
that notifications should have on/off mutability (High consensus) (Q7). Of the statements that
should trigger an alert/alarm (e.g., low battery, change in blood loss rate, misplaced tourniquet),
every answer was judged to be very important and critical by consensus (Q8).
C
C
Decision Support. There were 2 questions: one concerning the degree at which a tourniquet
should be able to advise or direct the user (Q9) and one concerning the degree of autonomy a
A
tourniquet should have (Q10). Minimum consensus was achieved for 3 items on Q9: monitoring
notifications, recommended actions, and delivery of detailed instructions. For Q10, there was
High consensus that it is very important and critical that a tourniquet be capable of manual
operation and could be automatic with required user approval.
13
Tourniquet Usage. In regards to tourniquet force (Q11), high consensus was achieved that the
following were very important and critical: device confirmation requirement, user prompting
automatic force change, and the tourniquet would stay tightened upon system failure. No
consensus was reached for the statement that force pressures should never be automatically
changed. On reusability (Q12), two items were deemed very important and critical by Moderate
consensus: that most components and the expensive parts should at least be reusable.
D
Key findings from all survey and working group meetings are compiled in Table 1.
TE
Discussion:
We achieved consensus on a total of 89 out of 135 items that discussed key tourniquet features
EP
and capabilities, although each item was not unique, and some were duplicative to ensure
stability in responses. The totals of all High, Moderate, and Minimum consensus was 12 items in
survey round 1, 30 items in survey round 2, and 47 items in round 3. The compiled key findings
are broken down into categories with key features in Table 1 that can be used as a guideline for
C
future development of enhanced tourniquets.

C
Our study also reaffirmed much of the necessity of form and function of current tourniquet
A
systems, acknowledging that improvement in basic areas is always desirable (e.g., lower cost,
easy to use by anyone, lighter weight). The study affirmed that there is a need for addressing
prolonged care conditions such as longer use times and use in all MASCAL and CUF scenarios.
Many of the items that would constitute “next generation” features and capabilities include
technologies that take advantage of novel sensing, display, and control mechanisms for
14
monitoring, alerts, and automation. Overall, our study showed that semi-automated features are
desirable and will play a critical role in advancement of tourniquet systems.

There were three rounds of surveys needed to achieve stability in our answers. It was determined
that a fourth survey round would be unnecessary based on the consistency of survey answers.
D
Topic statements were formulated using information from various sources such as Joint Trauma
System committee meeting reports, literature review, and discussion with experts. Care was also
TE
taken to include target use case scenarios (prolonged care) and potential end users (prehospital
medics). It was recognized that explaining these conditions and defining key terms when
formulating the survey would be critical to ensuring panelists understood the context of survey
EP
topics and could respond as appropriately as possible.
The panelists confirmed the importance of various basic tourniquet features and use-case
C
scenarios. Although tourniquets can cause limb damage and reperfusion injury after only 2
hours, the panel’s consensus around using tourniquets greater than 2 hours and using tourniquets
C
in a variety of environments (CUF, MASCAL, etc.) reaffirmed the utility of tourniquets in
prolonged care scenarios as lifesaving measures, even at the potential cost of limb damage. Some
A
other basic features were noted or even expected to draw consensus including the need for low
weight, appropriate materials, being used one-handed, and at least some degree of reusability.
There was Moderate consensus around a device needing to be stand-alone (i.e., not integrated
into a uniform) as well as needing minimal training to use.
15
Considering one of the “smart” functions that could be provided by a tourniquet, panelists agreed
on the importance of data storage and transfer capabilities. Specifics around what data is
important and how to transfer that data were addressed in Survey 3 and determined time since
application as the most important for tourniquet use; this data should be presented in at least a
written format. Other data that was agreed on as critical included blood pressure, heart rate, and
(to a lesser extent) tissue oxygenation. Data could be recorded and displayed on a screen and/or
D
transferred via wired connection to another device as necessary.
TE
Tourniquets could also use collected data to monitor patient vitals and provide alerts or give
instructions, depending on what recording functions an enhanced tourniquet may possess.
Alarms and/or alerts could be useful for warning a caregiver when something is going wrong that
EP
they might not otherwise notice. Automated notices could be displayed on a screen or given as
an audio alert, although there were concerns that audio alerts could give away position to an
adversary. As such, it was agreed that muting and volume functions would be critical. The 3
most important items agreed upon by panelists were low battery, device malfunction, and change
C
in blood loss rate.

C
As for automated tourniquet function (i.e., automated tightening/loosening to maintain

A
occlusion), there was clear hesitation around fully automated tourniquet deployment and even
automated functions in general. Dubiousness around automated systems revolved around
concern for system failures in terms of failure to activate, inappropriate activation, or failure after
activation. As such, it was clear that semi-automated function was critical (i.e., manual backup
always available, user-confirmation requirements for changing tourniquet force) and that
16
automated tourniquets, should they fail, should fail ON. In other words, pressure should be
maintained even if automated functions have become disabled. To circumvent automated
functionality, a tourniquet could also provide instructions to the user, with some agreement that a
tourniquet could provide recommended.

Limitations of this study include panelist involvement, where the military representation far
D
outweighed other industry types. Dropouts from the study were consistent through each survey
step, however agency representation of the panelists were spread out amongst various types of
TE
SMEs so we therefore do not believe there was a bias towards the end of the survey rounds that
may skew to one side or another (Supplemental Digital Content, Table 2,
http://links.lww.com/TA/D504). Another limitation is that we asked panelists to envision

EP
hypothetical innovations that could be useful for a future tourniquet even though these
capabilities currently do not exist on a tourniquet system. Several comments were made such as
“how would this work” and “this technology does not exist” may explain why some panelists
regarded fully autonomous tourniquets as not important and highly relied on manual operations
C
as fallback option. Adoption of these hypothetical tourniquet devices are akin to our current
C
mindset of adopting newly developed digitized devices; they are harder to adopt and require key
components such as technology support, focus on end-user experience, and inclusion of clinician
A
champions(23). Other concerns were how sensors could be integrated into these enhanced
tourniquet devices and evaluating other types of garments for the integration of tourniquets aside
from typical combat uniforms. Although there was a general consensus that integration into a
uniform was not feasible due to the complexity of placement, maintenance, and reliability, the
17
panelists agreed that there should be future research and development and thorough evaluation of
uniform-integrated devices.
Conclusions:
Given the panelists’ consensus, there is clear room for innovation in the “next generation”
tourniquet space. Based on the outcome of these surveys, a series of recommendations for next
D
generation tourniquets has been devised which can be used as a baseline for future development.
We sought a comprehensive analysis of tourniquet recommendations that combine potential use
TE
of new technological innovations. Although this list is large, we recognize that not all of these
features may be possible in one single tourniquet and perhaps a portfolio of multiple tourniquets
that are appropriate in different use-case scenarios may be more useful in both military and
EP
civilian markets. Indeed, tourniquets with enhanced capabilities based on the results of this
survey process may be most specific for use by a medical provider rather than widespread use by
individuals without medical training, particularly because of the abandonment of cost as a
significant factor. The Delphi methodology used herein could, however, be used to identify
C
future developments for a tourniquet that could be used universally by laypersons to aid in the
C
most pressing concerns, such as proper placement for cessation of limb blood flow. Indeed, one
recently developed tourniquet system, the Layperson Audiovisual Assist Tourniquet (LAVA
A
TQ), possesses features that directly instruct a lay user in proper tourniquet application. The
results of a recent study suggest that the LAVA TQ could reduce tourniquet application time and
increase successful application rates relative to the common combat application tourniquet by
leveraging features that instruct and guide users(24).
18
We recommend continued efforts in testing and validating new tourniquet systems, especially
when new capabilities or features are implemented(25). Novel enhanced tourniquets should also
be thoroughly evaluated and validated in multiple test case scenarios with appropriate simulator
models that are capable of mimicking and capturing the appropriate data, especially if novel
sensing capabilities are required. The development of a validation framework to test these new
tourniquets is warranted to ensure the safety and effectiveness of the device and robustness for
D
all environments.
TE
EP
C
C
A
19
SDC Content includes CREDES guideline checklist, demographics, and associated survey
results for rounds 1-3.

1. SDC Table 1: Guidance on Conducting and Reporting Delphi Studies Checklist

2. SDC Table 2: Panelist Associated Agency, Years of Experience, and Expertise
3. SDC Figure 1: Distribution of Panelist Tourniquet Range of Experience
D
4. SDC Figure 2: Distribution of Panelist Tourniquet Expertise Level
5. SDC Table 3: Survey 1 Likert Score, Importance, and Consensus Level Results
TE
6. SDC Table 4: Survey 2 Likert Scores, Agreements, and Consensus Level Results
7. SDC Table 5: Survey 3 Likert Scores, Importance, and Consensus Level Results
EP
C
C
A
20
References:
1. Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, et al. Death on the
battlefield (2001-2011): implications for the future of combat casualty care. J Trauma
Acute Care Surg. 2012;73(6 Suppl 5):S431-7.

2. Kragh JF, Jr., Dubick MA, Aden JK, McKeague AL, Rasmussen TE, Baer DG, et al. U.S.
Military use of tourniquets from 2001 to 2010. Prehosp Emerg Care. 2015;19(2):184-90.
D
3. Howard JT, Kotwal RS, Stern CA, Janak JC, Mazuchowski EL, Butler FK, et al. Use of
Combat Casualty Care Data to Assess the US Military Trauma System During the
TE
Afghanistan and Iraq Conflicts, 2001-2017. JAMA Surg. 2019;154(7):600-8.
4. Montgomery HR, Hammesfahr R, Fisher AD, Cain JS, Greydanus DJ, Butler FK, Jr., et
al. 2019 Recommended Limb Tourniquets in Tactical Combat Casualty Care. J Spec
EP
Oper Med. 2019;19(4):27-50.
5. Kragh JF, Jr., Swan KG, Smith DC, Mabry RL, Blackbourne LH. Historical review of
emergency tourniquet use to stop bleeding. Am J Surg. 2012;203(2):242-52.
6. Kragh JF, Darrah M, Gradilla C, Salinas J, Aden JK, Dubick MA. An intelligent
C
tourniquet system to stop traumatic extremity bleeding. Am J Emerg Med.

C
2014;32(11):1419-21.
7. Parizad N, Hassanpour A, Goli R. Preventing the complications of forgotten tourniquet

A
by using intelligent tourniquet: A letter to the editor. Int J Surg Case Rep.
2022;90:106402.
8. Remondelli MH, Remick KN, Shackelford SA, Gurney JM, Pamplin JC, Polk TM, et al.
Casualty care implications of large-scale combat operations. J Trauma Acute Care Surg.
2023;95(2S Suppl 1):S180-S4.
21
9. Keenan S, Riesberg JC. Prolonged Field Care: Beyond the "Golden Hour". Wilderness
Environ Med. 2017;28(2s):S135-s9.
10. Mohr CJ, Keenan S. Prolonged Field Care Working Group Position Paper: Operational
Context for Prolonged Field Care. J Spec Oper Med. 2015;15(3):78-80.

11. Drew B, Bird D, Matteucci M, Keenan S. Tourniquet Conversion: A Recommended
Approach in the Prolonged Field Care Setting. J Spec Oper Med. 2015;15(3):81-5.
D
12. Shackelford SA, Butler FK, Kragh JF, Stevens RA, Seery JM, Parsons DL, et al.
Optimizing the Use of Limb Tourniquets in Tactical Combat Casualty Care: TCCC
TE
Guidelines Change 14-02. J Spec Oper Med. 2015;15(1):17-31.
13. Mould-Millman NK, Baidwan NK, Beaty B, Suresh K, Dixon JM, Patel C, et al.
Prolonged Casualty Care: Extrapolating Civilian Data to the Military Context. J Trauma
EP
Acute Care Surg. 2022.
14. Cohen AB, Davis M, Herman SEM. Prolonged Field Care Research Approach and Its
Relevance to Civilian Medicine. Mil Med. 2021;186(5-6):123-8.
15. Lee C, Porter KM, Hodgetts TJ. Tourniquet use in the civilian prehospital setting. Emerg
C
Med J. 2007;24(8):584-7.
C
16. Holcomb JB, Dorlac WC, Drew BG, Butler FK, Gurney JM, Montgomery HR, et al.
Rethinking Limb Tourniquet Conversion in the Pre-Hospital Environment. J Trauma

A
Acute Care Surg. 2023.
17. Hsu C-C. & Sandford, BA (2007). The Delphi technique: Making sense of consensus.
Practical Assessment, Research & Evaluation.12(10):1-8.
22
18. Black N, Murphy M, Lamping D, McKee M, Sanderson C, Askham J, et al. Consensus
Development Methods: A Review of Best Practice in Creating Clinical Guidelines.
Journal of Health Services Research & Policy. 1999;4(4):236-48.

19. Azadi T, Sadoughi F, Khorasani-Zavareh D. Using the Modified Delphi Method to

Propose and Validate Components of a Child Injury Surveillance System for Iran.
Perspect Health Inf Manag. 2021;18(Winter):1k.
D
20. NC. D. The Delphi Method: an experimental study of group opinion Santa Monica, CA:
RAND Coportation; 1969 [cited 2022 2 FEB, ]. Available from:
TE
https://www.rand.org/pubs/research_memoranda/RM5888.html. Accessed 02-02-2022
21. Turnbull AE, Sahetya SK, Needham DM. Aligning critical care interventions with patient
goals: A modified Delphi study. Heart Lung. 2016.

EP
22. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ.
1995;311(7001):376-80.
23. Smuck M, Odonkor CA, Wilt JK, Schmidt N, Swiernik MA. The emerging clinical role
of wearables: factors for successful implementation in healthcare. NPJ Digit Med.

C
2021;4(1):45.
C
24. Goolsby C, Jonson CO, Goralnick E, Dacuyan-Faucher N, Schuler K, Kothera C, et al.
The Untrained Public's Ability to Apply the Layperson Audiovisual Assist Tourniquet vs
A
a Combat Application Tourniquet: A Randomized Controlled Trial. J Am Coll Surg.
2023;236(1):178-86.
25. Heldenberg E, Aharony S, Wolf T, Vishne T. Evaluating new types of tourniquets by the
Israeli Naval special warfare unit. Disaster Mil Med. 2015;1:1.
23
D
TE
Figure1: Flowchart of survey participation and panel discussion rounds
EP
24
C
C
A
Figures:
D
TE
EP
25
C
C
Figure 1
A
Tables
Table 1 Compilation of Key Tourniquet Features and Recommendations
Category Highly Recommend Do Not Recommend
Environment Usable in all circumstances within CUF,
MASCAL
Time to Use Longer than 2 hours use

Application One-handed application Integrated in uniform
Applied by anyone Can be only used/monitored by medic
Display and Data Display on screen or written

Transfer Data transfer (wireless or wired)
Data storage of medically relevant
D
information
Alarms (malfunction, low battery, changes in
vitals, tourniquet tension, etc)
Data Features Time of application
TE
Heart rate
Blood pressures
Oxygenation
Reusability Reusable in whole or in part Requires maintenance for reusability
Automation Semi-automated occlusion with user approval
and device confirmation
Monitoring Display of time and medically relevant
information
EP
Alarms (malfunction, low battery, changes in
vitals, tourniquet tension, etc)
Generic audio alarms with mutable ability Voice alarms, non-mutable
Provide recommended actions
Training Minimal training specific to device Requiring more than one training event
specific to device
Manufacturing Limit cost
Limit weight
C
Materials Pain-minimization properties

Fail-safes Fail-safe on with manual ability to apply or Fail-safe off
deactivate
C
A
26
Supplemental Digital Content
SDC Table 1: Guidance on Conducting and Reporting Delphi Studies (CREDES) Checklist
SDC Table 1: Guidance on Conducting and Reporting Delphi Studies (CREDES)

Checklist
Rationale for Delphi Technique

Justification. The choice of the Delphi technique as a method of systematically Background,
collating expert consultation and building consensus needs to be well justified. page 1-2
D
Planning and Design
Planning and process. The Delphi technique is a flexible method and can be adjusted Methods,
to the respective research aims and purposes. Any modifications should be justified by page 2
a rationale and be applied systematically and rigorously
TE
Definition of consensus. Unless not reasonable due to the explorative nature of the Methods,
study, an a priori criterion for consensus should be defined. This includes a clear and pages 3-4
transparent guide for action on (a) how to proceed with certain items or topics in
the next survey round, (b) the required threshold to terminate the Delphi process and
(c) procedures to be followed when consensus is (not) reached after one or more
iterations
EP
Study Conduct
Informational input. All material provided to the expert panel at the outset of the Methods,
project and throughout the Delphi process should be carefully reviewed and piloted in page 4
advance in order to examine the effect on experts’ judgements and to prevent bias
Prevention of bias. Researchers need to take measures to avoid directly or indirectly No conflicts
influencing the experts’ judgements. If one or more members of the research team reported
have a conflict of interest, entrusting an independent researcher with the main
coordination of the Delphi study is advisable
C
Interpretation and processing of results. Consensus does not necessarily imply the Methods,
‘correct’ answer or judgement; (non)consensus and stable disagreement provide page 4;
informative insights and highlight differences in perspectives concerning the topic in Results page
C
question 5
External validation. It is recommended to have the final draft of the resulting guidance Not reviewed by
reviewed and approved by an external board or authority before publication external board
and dissemination
A
Reporting
Purpose and rationale. The purpose of the study should be clearly defined and Background,
demonstrate the appropriateness of the use of the Delphi technique as a method to page 2
achieve the research aim. A rationale for the choice of the Delphi technique as the
most suitable method needs to be provided
Expert panel. Criteria for the selection of experts and transparent information on Methods (Panel
recruitment of the expert panel Selection) page
2
27
Description of the methods. The methods employed need to be comprehensible; this Methods
includes information on preparatory steps, piloting of material and survey instruments, (Study
design of the survey instrument(s), the number and design of survey Design) page
rounds, methods of data analysis, processing and synthesis of experts’ responses to 3
inform the subsequent survey round and methodological decisions taken by the
research team throughout the process

Procedure. Flow chart to illustrate the stages of the Delphi process, including a Figure 1
preparatory phase, the actual ‘Delphi rounds’, interim steps of data processing and SDC Figure 2
analysis, and concluding steps SDC Figure 3
Definition and attainment of consensus. It needs to be comprehensible to the reader Methods

how consensus was achieved throughout the process, including strategies to deal with (Analysis and
D
non-consensus Criteria for
Consensus)
page 4
Results. Reporting of results for each round separately is highly advisable in order to Results pages 4-
TE
make the evolving of consensus over the rounds transparent. This includes figures 7
showing the average group response, changes between rounds, as well as any
modifications of the survey instrument such as deletion, addition or modification of
survey items based on previous rounds
Discussion of limitations. Reporting should include a critical reflection of potential Discussion
limitations and their impact of the resulting guidance pages 9-10
EP
Adequacy of conclusions. The conclusions should adequately reflect the outcomes of Conclusion page
the Delphi study with a view to the scope and applicability of the resulting practice 10-11
guidance
Publication and dissemination. The resulting guidance should be clearly identifiable This
from the publication, including recommendations for transfer into practice and publication
C
implementation. A dissemination plan should include endorsement of the +

guidance by professional associations and health care authorities to facilitate Poster
implementation presentation at
national meeting
C
A
28
SDC Table 2: Panelist Associated Agency, Years of Experience, and Expertise
SDC Table 2 : Panelist Associated Agency, Years of Experience, and Expertise

Round 1 Round 2 Round 3
Agency n % n % n %
Govt 26 76% 19 76% 12 75%
Industry 5 15% 4 16% 2 13%
Academia 2 6% 2 8% 1 6%
Other 1 3% 0 0% 1 6%
D
Total 34 100% 25 100% 16 100%
Range years of Round 1 Round 2 Round 3

experience Panelist n, (%) Panelist n, (%) Panelist n, (%)
TE
0-2 years 3 (9%) 1 (4%) 2 (12.5%)
3-5 years 3 (9%) 3 (12%) 3 (19%)
5-10 years 6 (18%) 6 (24%) 1 (6%)
10-15 years 5 (14%) 3 (12%) 3 (19%)
15+ years 17(50%) 11 (44%) 5 (31%)
No response 0 (0%) 1 (4%) 2 (12.5%)
EP
Tourniquet expertise Round 1 Round 2 Round 3
Panelist n, (%) Panelist n, (%) Panelist n, (%)
Novice 6 (18%) 4 (16%) 3 (19%)
Intermediate 10 (29%) 8 (32%) 5 (31%)
Experts 16 (47%) 10 (40%) 5 (31%)
No Response 2 (6%) 3 (12%) 3 (19%)
C
C
A
29
SDC Figure 2: Distribution of Panelist Tourniquet Range of Experience
DISTRIBUTION OF PANELIST TOURNIQUET

RANGE OF EXPERIENCE BY ROUNDS

50%
D
44%
TE 31%
Round 1
Round 2
24%
Round 3
19%
19%
18%
EP 14%
13%
13%
12%
12%
9%
9%
6%
4%
4%
0%
0-2 YEARS 3-5 YEARS 5-10 YEARS 10-15 YEARS 15+ YEARS NO RESPONSE
C
SDC Figure 3: Distribution of the panelist’ listed range of years of tourniquet experience by each survey
round. Round 1 in Blue, Round 2 in Red, Round 3 in Green.
C
A
30
SDC Figure 2: Distribution of Panelist Tourniquet Expertise Level
Distribution of Panelist Expertise Level by Rounds

50%
45%
40%
35%
30%
25%
D
20%
15%
10%
5%
TE
0%
Novice Intermediate Experts No Response
Round 1 Round 2 Round 3
SDC Figure 2: Distribution of the panelist’ listed expertise level by each Round listed by percentages.
Round 1 in Blue, Round 2 in Red, Round 3 in Green.
EP
C
C
A
31
SDC Table 3: Survey 1 Likert Score, Importance, and Consensus Level Results
SDC Table 3: Survey 1 Likert Score, Importance, and Consensus Level Results
Survey Topic Statement Median Importance Consensus Consensus
Likert Score of Statement Level (Highly Level (Not

(Scale 1-10) Important) Important)
Scores ≥ 7 Scores ≤ 4
*Environment [used in circumstances within care 10 Highly 91% 3%

under fire, MASCAL, etc.] Important
*Materials [material consideration such as 8.5 Highly 85% 3%
antimicrobial, tension, buckling, etc] Important
D
*Use greater than 2 hours [use greater than 2 8 Highly 76% 0%
hours to address PFC needs] Important
*One handed usability [can be used one-handed] 8 Highly 76% 6%
Important
TE
*Data Transfer [able to hold data; could be 8 Highly 74% 9%
transferred to another platform] Important
*Semi-automated Deflation [able to deflate upon 8 Highly 71% 6%
user confirmation] Important
*Weight [should be below a certain weight 8 Highly 71% 9%
threshold] Important
†Non-integrated, stand-alone device 8.5 Highly 68% 15%
EP
[independent, non-integrated, e.g. into uniform] Important
†Semi-automated (Inflation) [once placed, must 8 Highly 62% 9%
be deployed by a user first] Important
†Training [can be used without any or with 8 Highly 62% 9%
minimal training] Important
‡Cost [should be below a certain cost] 7 Highly 53% 12%
Important
Alarms/Alerts [should have alarm that is visual 6 Neutral 47% 15%
C
and/or audio for medical attention]

Automated Deflation [once applied, automatic 5.5 Neutral 41% 35%
deflation based on sensor/physiological
parameter]
C
Automated (Inflation) [once placed, automatic 6 Neutral 35% 24%

deployment based on sensor/physiological
parameter]
Power Supply [should be battery operated and 5 Neutral 29% 38%
rechargeable]
A
Use less than 2 hours [must only be used short 5 Neutral 26% 32%
term to prevent injury or complications]
‡Integrated within uniform [integrated with 3.5 Not 24% 50%
uniform, fully-automated, and deployed with Important
safe-guards]
*=High consensus (70%+)
†=Moderate consensus (60%-70%)
‡=Minimum consensus (50%-60%)
32
SDC Table 4: Survey 2 Likert Scores, Agreements, and Consensus Level Results
SDC Table 4: Survey 2 Likert Scores, Agreements, and Consensus Level Results
Section 1
Statement Median Likert Agreement Consensus Consensus

Score (Scale 1-7) 7 of Statement Level (Highly Level (Highly
= Highly Agree 1 = Agree) Scores ≥ Disagree)
Highly Disagree 5 Scores ≤ 3

* Tourniquets should be able to be 7 Highly Agree 84% 16%
used in circumstances within care
under fire, mass casualty, not just
D
prolonged field care.
* A tourniquet can be used for greater 6 Highly Agree 72% 16%
than 2 hours, if necessary.
† A tourniquet should be able to be 6 Highly Agree 68% 28%
TE
applied by anyone and monitored by
anyone.
† Integration of a tourniquet within a 6 Highly Agree 60% 36%
uniform is NOT a feasible solution.
† One-handed application of 5 Highly Agree 60% 32%
tourniquets may be beneficial but not
necessary
EP
‡ Aside from this project, more 5 Highly Agree 52% 32%
research and development should be
conducted for a tourniquet integrated
within a uniform.
‡ A tourniquet should be able to be 3 Highly 36% 52%
applied by anyone, but only monitored Disagree
by a combat medic or other medical
provider.
C
Section 2
Question 2A: Why is Integration of a Median Rank Scale Importance Consensus Consensus
tourniquet within a uniform NOT a (Scale 1-9) 1 = of Statement Level (Most Level (Least
feasible solution? Most Important 9 Important) Important)
= Least Important Scores ≤ 3 Scores ≥ 7
C
Laundering & Maintenance 4 Neutral 45% 15%

Difficult to deploy 4 Neutral 40% 20%
Wear and Tear 5 Neutral 40% 15%
Torn uniform = broken device 5 Neutral 40% 30%
A
Reusability 5 Neutral 30% 30%

Accidental deployment 5 Neutral 30% 25%
† More Expensive 7 Least 30% 65%
Important
Determining placement 6 Neutral 25% 40%
† Too many body variations 7 Least 20% 60%
Important
Question 2B: Why should a tourniquet Median Rank Scale Importance Consensus Consensus
NOT be used for greater than 2 hours? (Scale 1-4) 1 = of Statement Level (Most Level (Least
Most Important 4 Important) Important)
33
* Limb loss 2 Most 71% 29%
Important
‡ Effects of release 2 Most 59% 41%
Important
‡Lack of removal knowledge 2 Most 53% 47%
Important
* Durability 4 Least 18% 82%

Important
Question 2C: A fully automated, stand- Median Rank Scale Importance Consensus Consensus
alone tourniquet should utilize which (Scale 1-4) 1 = of Statement Level (Most Level (Least
mechanism? Most Important 4 Important) Important)
D
† Rotational-ratchet 2 Most 61% 39%
Important
‡ Pneumatic 2 Most 52% 48%
Important
TE
‡ Windlass 3 Least 48% 52%
Important
† Linear-ratchet 3 Least 39% 61%
Important
Question 2D: A semi-automated, Median Rank Scale Importance Consensus Consensus
stand-alone tourniquet should utilize (Scale 1-4) 1 = of Statement Level (Most Level (Least
which mechanism? Most Important 4 Important) Important)
EP
‡ Rotational-ratchet 2 Most 57% 43%
Important
‡ Pneumatic 2 Most 52% 48%
Important
‡ Linear-ratchet 3 Least 48% 52%
Important
‡ Windlass 3 Least 43% 57%
Important
C
Question 2E: A fully automated, stand Median Rank Scale Importance Consensus Consensus
sensing mechanism for maintaining Most Important 3 Important) Important)
proper force pressure? = Least Important Scores ≤ 1 Scores ≥ 3
C
Ultrasound capability 2 Neutral 39% 35%

Blood Pressure 2 Neutral 30% 17%
Hemorrhage sensing mechanism 2 Neutral 30% 48%
Question 2F: A fully automated stand Median Rank Scale Importance Consensus Consensus
A
sensing mechanisms for deactivation? Most Important 3 Important) Important)
Ultrasound capability 2 Neutral 36% 39%
Hemorrhage sensing mechanism 2 Neutral 36% 39%
Blood Pressure 2 Neutral 27% 22%
Question 2G: In the development of a Median Rank Scale Importance Consensus Consensus
tourniquet, which properties are most (Scale 1-3) 1 = of Statement Level (Most Level (Least
important in choosing a tourniquet Most Important 3 Important) Important)
structural material? = Least Important Scores ≤ 1 Scores ≥ 3
Mechanism strength to withstand high 2 Neutral 36% 45%
tension
34
Mechanical durability to withstand 2 Neutral 36% 27%
prolonged storage, wear-and-tear
Physical durability properties to use in 2 Neutral 27% 27%
wet/hot/cold/caustic environment
Question 2H: In the development of a Median Rank Scale Importance Consensus Consensus
tourniquet, which properties are most (Scale 1-2) 1 = of Statement Level (Most Level (Least
important in choosing an additive Most Important 2 Important) Important)

material? = Least Important Scores ≤ 1 Scores ≥ 2
* Pain-minimization properties and 1 Most 96% 4%
design Important
* Antimicrobial properties 2 Least 4% 96%
Important
D
Question 2I: Which concerns are Median Rank Scale Importance Consensus Consensus
unacceptable outcomes? (Scale 1-7) 1 = of Statement Level (Most Level (Least
Most Important 7 Important) Important)
TE
† Fail to activate 1 Most 68% 11%
Important
† Inappropriate or premature 2 Most 63% 5%
deactivation Important
Inappropriate Pressure 3 Neutral 32% 5%
Inappropriate or premature activation 4 Neutral 16% 26%
Automated system would increase 5 Neutral 0% 26%
weight
EP
Automated system would require 5 Neutral 11% 47%
power
* Automated system would increase 6 Least 11% 79%
cost Important
Question 2J: How much training Median Rank Scale Importance Consensus Consensus
should be required to effectively use (Scale 1-4) 1 = of Statement Level (Most Level (Least
the tourniquet? Most Important 4 Important) Important)
C
† None 1 Most 62% 38%

Important
† At least one tourniquet training 2 Most 62% 38%
specific to device Important
C
‡ Similar to AED - device should 2 Most 52% 48%

prompt user Important
* More than one tourniquet training 4 Least 24% 76%
specific to device Important
A

35
SDC Table 5: Survey 3 Likert Scores, Importance, and Consensus Level Results
SDC Table 5: Survey 3 Likert Scores, Importance, and Consensus Level Results
Category Median Rank Importance of Consensus Consensus Consensus
Scale (Scale 1- Statement Level (Very Level (Very Level (Not

9) 1-3 Not Important Important Important)
Important, 4-6 and Critical Not Critical) Scores ≤ 3
Very Important ) Scores ≥ 7 Scores 3-7

Not Critical, 7-9
Very Important
And Critical
D
Data Collection and Transfer
Q1: What kind of data is relevant for tourniquet use?
*Time since application 9 Very Important 93% 7% 0%
and Critical
TE
‡Heart Rate 7 Very Important 53% 20% 27%
and Critical
Blood pressures 6 Very Important 47% 33% 20%
(upstream/proximal) but Not Critical
(downstream/distal) but Not Critical
Tourniquet force pressures 6 Very Important 47% 40% 13%
EP
but Not Critical
Tissue oxygenation 5 Very Important 33% 40% 27%
(upstream/proximal) but Not Critical
Q2: During role of care transition, what data is important during transfer to the next provider?
*Time since application 9 Very Important 93% 7% 0%
and Critical
C
†Heart Rate 7 Very Important 67% 33% 0%

and Critical
†Blood pressures 7 Very Important 60% 33% 7%
(upstream/proximal) and Critical
C
‡Tissue oxygenation 7 Very Important 53% 33% 13%

(upstream/proximal) and Critical
‡Tourniquet force pressures 5 Very Important 33% 53% 13%
A
but Not Critical

Q3: How should data transfer occur locally (directly with the tourniquet user)?
*Written (Dedicated space to 9 Very Important 87% 13% 0%
write) and Critical
†Screen (shown as part of 7 Very Important 67% 33% 0%
tourniquet in real time) and Critical
Wireless (Can be transferred by 6 Very Important 33% 40% 27%
streaming to another device) but Not Critical
Orally (relayed to the device) 5 Very Important 27% 33% 40%
36
but Not Critical
‡Wired (transferred via USB to 5 Very Important 27% 53% 20%
another device) but Not Critical
‡Audio (data relayed through 3 Not Important 7% 40% 53%
speaker)
Q4: How should data transfer occur afterwards to the next provider?
*Written (Dedicated space to 9 Very Important 80% 13% 7%

write) and Critical
†Screen (shown as part of 7 Very Important 67% 33% 0%
tourniquet in real time) and Critical

Wireless (Can be transferred by 5 Very Important 40% 40% 20%
streaming to another device) but Not Critical
D
‡Wired (transferred via USB to 5 Very Important 33% 53% 13%
another device) but Not Critical
‡Audio (data relayed through 3 Not Important 13% 27% 60%
speaker)
TE
Q5: What ports would be useful on the tourniquet?
No Ports 5 Very Important 21% 43% 36%
but Not Critical
‡USB (For data and audio) 5 Very Important 27% 53% 20%
but Not Critical
†Aux Jack (For audio delivery to 4 Very Important 0% 67% 33%
speakers/headphones) but Not Critical
Alarms and Alerts
EP
Q6: Alarms/Alerts on the tourniquet should be
*Displayed on a screen 8 Very Important 86% 14% 0%
and Critical
†Audio generic (pings/beeps) 7 Very Important 64% 21% 14%
and Critical
‡Audio language (computer voice 6.5 Very Important 50% 36% 14%
describing alert) but Not Critical
‡Displayed on another screen 6 Very Important 29% 57% 14%
C
(data transfer to separate device) but Not Critical

Haptic (vibrations) 4.5 Very Important 36% 29% 36%
but Not Critical
Q7: To what degree should notifications be customizable to the tourniquet user?
C
*On/Off (Device can be mutable) 8 Very Important 79% 7% 14%

and Critical
†Presets (2-4 options for what 7 Very Important 64% 29% 7%
sets of notifications are given) and Critical
A
‡Master volume (volume for all 7 Very Important 57% 36% 7%

notifications can be adjusted at and Critical
once)
Customizable (each specific alarm 6 Very Important 43% 43% 14%
can be turned on/off with but Not Critical
buttons/screen/app,etc)
Volume mixer (volume for each 5.5 Very Important 21% 57% 21%
notification can be adjusted but Not Critical
separately)
None (all notifications should be 5 Very Important 38% 23% 38%
preset and nonchangeable) but Not Critical
37
Q8: What should trigger an alert/alarm?
*Low battery (If the device 9 Very Important 93% 7% 0%
requires power) and Critical
*Device malfunction 9 Very Important 93% 7% 0%
and Critical
*Change in blood loss rate 8 Very Important 93% 0% 7%
and Critical
†Blood pressure change 8 Very Important 67% 27% 7%
and Critical
*Tension issues (If a higher/lower 7 Very Important 93% 7% 0%

amount of tension than expected and Critical
is used/required to stop
D
hemorrhaging)
*Low blood partial oxygenation 7 Very Important 73% 13% 13%
and Critical
*Poor connection (If device 7 Very Important 73% 27% 0%
TE
transmits a signal via and Critical
Bluetooth/cell/satellite/etc)
†Misplaced tourniquet {If a 7 Very Important 67% 27% 7%
tourniquet is placed too high/low and Critical
on the limb)
†Pulse change (Outside of a range 7 Very Important 60% 20% 20%
either preset or set by user) and Critical
Decision Support
EP
Q9: To what degree should the tourniquet be able to advise the user?
‡Monitoring notifications 7 Very Important 57% 36% 7%
(Alarms/alerts for physiological and Critical
occurrences with the patient
‡Recommendations (The device 7 Very Important 57% 43% 0%
should recommend actions be and Critical
taken like ‘tighten tourniquet’
and ‘apply CPR’)
C
Detailed instructions (Instructions 6 Very Important 29% 57% 14%

a person with no previous but Not Critical
medical knowledge could
reasonably fulfill, like an AED)
C
None 4 Very Important 27% 36% 36%

but Not Critical
Q10: What degree of autonomy should the device be capable of?
*Manual operation (The user 9 Very Important 71% 21% 7%
A
operates the tourniquet with no and Critical

assistance from the device)
*Automatic with required user 7 Very Important 71% 29% 0%
approval (Device prompts user to and Critical
approve / deny actions)
†Monitoring and advice given to 7 Very Important 64% 36% 0%
the operator, manual operation and Critical
(Manual operation with
alerts/instructions/etc)
‡Monitoring with manual 7 Very Important 57% 36% 7%
operations (Device manual and Critical
operation, user receives data
38
from device)
Fully automatic (If user 5.5 Very Important 36% 43% 21%
approval/denial of an action is but Not Critical
not received for a certain time,
the action will be taken)
Tourniquet Usage
Q11: Please rate the following statements regarding tourniquet force pressures
*Device confirmation 8 Very Important 81% 19% 0%
requirement (Device double and Critical
check with user if applied

pressure was appropriate to stop
hemorrhaging)
D
*The user can prompt automatic 8 Very Important 75% 25% 0%
force pressure change (user can and Critical
indicate with a
button/screen/etc. for the device
to change to a certain pressure)
TE
*Tourniquet fail state is set to 8 Very Important 75% 13% 13%
‘ON’ (force pressure continuously and Critical
applied - Tourniquet will ‘fail on’
and stay tightened upon device
failure)
†TKT should have automatic force 7 Very Important 63% 38% 0%
pressure management that must and Critical
EP
be manually enabled
‡Tourniquet force pressure value 6.5 Very Important 50% 50% 0%
should be displayed but Not Critical
‡All force pressure changes 5 Very Important 25% 50% 25%
should be fully manual but Not Critical
TKT force pressure should never 4.5 Very Important 25% 44% 31%
be automatically changed (only but Not Critical
manual)
C
Q12: Should the tourniquet be reusable?

†Yes, most components 8 Very Important 62% 31% 8%
(Straps/buckles/etc. should be and Critical
replaced but any mechanical
C
pieces can be sanitized and

reused)
†Yes, but only the expensive 7 Very Important 69% 31% 0%
parts and Critical
A
No (The entire device should be 5 Very Important 31% 23% 46%

replaced after each use) but Not Critical
Yes (Entirely Reusable) 5 Very Important 23% 38% 38%
but Not Critical
39
D
TE
EP
40
C
C
A
D
TE
EP
41
C
C
A
D
TE
EP
42
C
C
A
D
TE
EP
43
C
C
A
D
TE
EP
44
C
C
A
D
TE
EP
45
C
C
A
D
TE
EP
46
C
C
A
D
TE
EP
47
C
C
A
D
TE
EP
48
C
C
A
D
TE
EP
49
C
C
A
D
TE
EP
50
C
C
A
D
TE
EP
51
C
C
A
D
TE
EP
52
C
C
A
D
TE
EP
53
C
C
A
D
TE
EP
54
C
C
A
D
TE
EP
55
C
C
A
D
TE
EP
56
C
C
A
D
TE
EP
57
C
C
A
D
TE
EP
58
C
C
A

Next Generation Tourniquet Recommendations For.596

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Next Generation Tourniquet Recommendations For.596

Uploaded by

Copyright:

Available Formats

Journal of Trauma and Acute Care Surgery, Publish Ahead of Print

Next Generation Tourniquet: Recommendations for Future Capabilities and

Sena R. Veazey, MS1 (sena.r.veazey.ctr@mail.mil, ORCID 0000-0001-9195-0850)

Darke R. Hull1,2 (hulldar@oregonstate.edu)

Jose Salinas, PhD1 (jose.salinas4.civ@mail.mil)

John F. Kragh, Jr, MD1 (john.f.kragh.civ@mail.mil)

Command, San Antonio TX

Correspondence: Sena Veazey, MS

US Army Institute of Surgical Research

3698 Chambers Pass

JBSA Fort Sam Houston, Texas 78234

provided as supplemental digital content (http://links.lww.com/TA/D505).

results of this research study.

or the U.S. Government.

Social Media Information:

development of devices to address #prolongedcasualtycare needs. Forging the next wave of

Social media handles: Twitter @usa_isr

Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to

way or used commercially without permission from the journal.

of engineering and automation technologies to provide advanced tourniquet features. A

the following surveys.

displays, semi-automated capabilities with inherent overrides, automated monitoring with

notifications and alerts, and provide recommended actions.

of a prehospital medical provider.

Study Type: Survey

Keywords: tourniquets, requirements, consensus, survey

methodology to establish a consensus, an agreement among a set of tourniquet subject matter

deliberately designed to facilitate exchange of information throughout regular working groups

and surveys with additional comments.

Regulatory Approval and Standards

experience in research, development, clinical use, or manufacturing based on our network of

manufacturing companies. We sought a heterogeneous group to represent broad experiences

option to participate. Additionally, we allowed panel participants to recommend other potential

nurses, engineers, physicians (emergency, surgeon, trauma), instructors, veterinarian, and

represented the US, Canada, Belgium, and Israel.

meeting and survey were not needed to complete the study.

meeting was then conducted to discuss the results.

The demographic breakdown of panelists is presented in Supplemental Digital Content, Table 2,

http://links.lww.com/TA/D504. The panelists predominantly consisted of those affiliated with

and their listed expertise level (Supplemental Digital Content, Figure 2,

reported and varied (47% expert to 17.6% novice).

consensus of statements’ importance are presented in Supplemental Digital Content, Table 3,

http://links.lww.com/TA/D504. Consensus was achieved for 12 total statements (7 High, 3

device end user (i.e., a prehospital medic).

Supplemental Digital Content, Table 4, http://links.lww.com/TA/D504. In Section 1, at least

that increased cost from automated systems was least important.

Digital Content, Table 5, http://links.lww.com/TA/D504).

operation and could be automatic with required user approval.

future development of enhanced tourniquets.

desirable and will play a critical role in advancement of tourniquet systems.

in a variety of environments (CUF, MASCAL, etc.) reaffirmed the utility of tourniquets in

into a uniform) as well as needing minimal training to use.

instructions, depending on what recording functions an enhanced tourniquet may possess.

in blood loss rate.

As for automated tourniquet function (i.e., automated tightening/loosening to maintain

automated functions in general. Dubiousness around automated systems revolved around

maintained even if automated functions have become disabled. To circumvent automated

tourniquet could provide recommended.

may skew to one side or another (Supplemental Digital Content, Table 2,

http://links.lww.com/TA/D504). Another limitation is that we asked panelists to envision

We sought a comprehensive analysis of tourniquet recommendations that combine potential use

individuals without medical training, particularly because of the abandonment of cost as a

leveraging features that instruct and guide users(24).