Tourniquet Training Effectiveness Study

NCT03538379 | Unknown

• 1 other identifier: 2018P000536
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma Injury; Hemorrhage

Keywords

Tourniquets; Bleeding Control Basic (B-Con) Course; Layperson training

Outcome Measures

Primary Outcomes (1)

• Correct Tourniquet Application

  Correct tourniquet application for each type of tourniquet tested. Correct application for all arms / types of tourniquets is defined as application pressure \> 250 mmHg, distance above injury of \> 2 inches, and time to application \< 2 minutes.

  Within 30 minutes of completing training

Secondary Outcomes (6)

• Total Blood loss

  Within 30 minutes of completing training

• Time to Tourniquet Application

  Within 30 minutes of completing training

• Pressure Applied by Tourniquet

  Within 30 minutes of completing training

• Demographic Predictors of Correct Tourniquet Application

  Within 30 minutes of completing training

• Willingness-to-assist in Emergency

  immediately before training and within 30 minutes of completing training

Study Arms (5)

Combat Application Tourniquet (CAT)

ACTIVE COMPARATOR

The combat application tourniquet (CAT) is the type of commercial tourniquet taught in the B-Con course as administered by the investigators. It will serve as the control group to which all other types of tourniquets, which are not explicitly taught in the course, are compared to.

Behavioral: Bleeding Control Basic (B-Con) Course

Sof Tourniquet (Sof-T)

ACTIVE COMPARATOR

The Sof-Tourniquet (Sof-T) is a commercial windlass type tourniquet similar to the CAT tourniquet in that it is based on a windlass mechanism. Its application not explicitly taught in the B-Con course.

Behavioral: Bleeding Control Basic (B-Con) Course

Stretch-Wrap-And-Tuck (SWAT) Tourniquet

ACTIVE COMPARATOR

The Stretch-Wrap-And-Tuck (SWAT) Tourniquet is a commercial elastic tourniquet. Its application not explicitly taught in the B-Con course.

Behavioral: Bleeding Control Basic (B-Con) Course

Rapid Application Tourniquet (RAT)

ACTIVE COMPARATOR

The Rapid Application Tourniquet (RAT) is a commercial elastic tourniquet similar to a bungee cord. Its application not explicitly taught in the B-Con course.

Behavioral: Bleeding Control Basic (B-Con) Course

Improvised Tourniquet

ACTIVE COMPARATOR

The improvised tourniquet arm will involve participants being given supplies to enable them to fashion a tourniquet. The supplies will include a leather belt, gauze, shoestring, and a rod to act as a windlass.

Behavioral: Bleeding Control Basic (B-Con) Course

Interventions

Bleeding Control Basic (B-Con) Course BEHAVIORAL

The American College of Surgeons Bleeding Control Basic Course will be provided to participants. This course consists of a 30-minute lecture followed by 30-minutes of hands-on training in hemorrhage control technique application. It teaches how to apply manual pressure and how to apply a Combat Application Tourniquet (CAT). The course will not vary from its typical administration for this study.

Combat Application Tourniquet (CAT); Improvised Tourniquet; Rapid Application Tourniquet (RAT); Sof Tourniquet (Sof-T); Stretch-Wrap-And-Tuck (SWAT) Tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in the Bleeding Control Basic Course

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Gillian Reny Stepping Strong Center for Trauma Innovation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (16)

• Rhee P, Joseph B, Pandit V, Aziz H, Vercruysse G, Kulvatunyou N, Friese RS. Increasing trauma deaths in the United States. Ann Surg. 2014 Jul;260(1):13-21. doi: 10.1097/SLA.0000000000000600.

  PMID: 24651132 BACKGROUND

• Kwon AM, Garbett NC, Kloecker GH. Pooled preventable death rates in trauma patients : Meta analysis and systematic review since 1990. Eur J Trauma Emerg Surg. 2014 Jun;40(3):279-85. doi: 10.1007/s00068-013-0364-5. Epub 2014 Jan 29.

  PMID: 26816061 BACKGROUND

• Kragh JF Jr, Walters TJ, Baer DG, Fox CJ, Wade CE, Salinas J, Holcomb JB. Survival with emergency tourniquet use to stop bleeding in major limb trauma. Ann Surg. 2009 Jan;249(1):1-7. doi: 10.1097/SLA.0b013e31818842ba.

  PMID: 19106667 BACKGROUND

• Kauvar DS, Dubick MA, Walters TJ, Kragh JF Jr. Systematic review of prehospital tourniquet use in civilian limb trauma. J Trauma Acute Care Surg. 2018 May;84(5):819-825. doi: 10.1097/TA.0000000000001826.

  PMID: 29432381 BACKGROUND

• Joint Committee to Create a National Policy to Enhance Survivability from Mass Casualty Shooting Events; Jacobs LM, Eastman A, Mcswain N, Butler FK, Rotondo M, Sinclair J, Wade DS, Fabbri WR. Improving Survival from Active Shooter Events: The Hartford Consensus. Bull Am Coll Surg. 2015 Sep;100(1 Suppl):32-4. No abstract available.

  PMID: 26477133 BACKGROUND

• Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc.

  PMID: 23192066 BACKGROUND

• Kotwal RS, Montgomery HR, Kotwal BM, Champion HR, Butler FK Jr, Mabry RL, Cain JS, Blackbourne LH, Mechler KK, Holcomb JB. Eliminating preventable death on the battlefield. Arch Surg. 2011 Dec;146(12):1350-8. doi: 10.1001/archsurg.2011.213. Epub 2011 Aug 15.

  PMID: 21844425 BACKGROUND

• Biddinger PD, Baggish A, Harrington L, d'Hemecourt P, Hooley J, Jones J, Kue R, Troyanos C, Dyer KS. Be prepared--the Boston Marathon and mass-casualty events. N Engl J Med. 2013 May 23;368(21):1958-60. doi: 10.1056/NEJMp1305480. Epub 2013 May 1. No abstract available.

  PMID: 23635020 BACKGROUND

• Teixeira PGR, Brown CVR, Emigh B, Long M, Foreman M, Eastridge B, Gale S, Truitt MS, Dissanaike S, Duane T, Holcomb J, Eastman A, Regner J; Texas Tourniquet Study Group. Civilian Prehospital Tourniquet Use Is Associated with Improved Survival in Patients with Peripheral Vascular Injury. J Am Coll Surg. 2018 May;226(5):769-776.e1. doi: 10.1016/j.jamcollsurg.2018.01.047. Epub 2018 Mar 29.

  PMID: 29605726 BACKGROUND

• Scerbo MH, Holcomb JB, Taub E, Gates K, Love JD, Wade CE, Cotton BA. The trauma center is too late: Major limb trauma without a pre-hospital tourniquet has increased death from hemorrhagic shock. J Trauma Acute Care Surg. 2017 Dec;83(6):1165-1172. doi: 10.1097/TA.0000000000001666.

  PMID: 29190257 BACKGROUND

• Scerbo MH, Mumm JP, Gates K, Love JD, Wade CE, Holcomb JB, Cotton BA. Safety and Appropriateness of Tourniquets in 105 Civilians. Prehosp Emerg Care. 2016 Nov-Dec;20(6):712-722. doi: 10.1080/10903127.2016.1182606. Epub 2016 May 31.

  PMID: 27245978 BACKGROUND

• Beaucreux C, Vivien B, Miles E, Ausset S, Pasquier P. Application of tourniquet in civilian trauma: Systematic review of the literature. Anaesth Crit Care Pain Med. 2018 Dec;37(6):597-606. doi: 10.1016/j.accpm.2017.11.017. Epub 2018 Jan 5.

  PMID: 29309952 BACKGROUND

• Butler FK Jr, Holcomb JB, Giebner SD, McSwain NE, Bagian J. Tactical combat casualty care 2007: evolving concepts and battlefield experience. Mil Med. 2007 Nov;172(11 Suppl):1-19. doi: 10.7205/milmed.172.supplement_1.1.

  PMID: 18154234 BACKGROUND

• Jacobs LM, Burns KJ, Langer G, Kiewiet de Jonge C. The Hartford Consensus: A National Survey of the Public Regarding Bleeding Control. J Am Coll Surg. 2016 May;222(5):948-55. doi: 10.1016/j.jamcollsurg.2016.02.013. Epub 2016 Mar 31. No abstract available.

  PMID: 27113518 BACKGROUND

• Sidwell RA, Spilman SK, Huntsman RS, Pelaez CA. Efficient Hemorrhage Control Skills Training for Healthcare Employees. J Am Coll Surg. 2018 Feb;226(2):160-164. doi: 10.1016/j.jamcollsurg.2017.11.003. Epub 2017 Nov 16.

  PMID: 29155270 BACKGROUND

• McCarty JC, Hashmi ZG, Herrera-Escobar JP, de Jager E, Chaudhary MA, Lipsitz SR, Jarman M, Caterson EJ, Goralnick E. Effectiveness of the American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types: A Randomized Clinical Trial. JAMA Surg. 2019 Oct 1;154(10):923-929. doi: 10.1001/jamasurg.2019.2275.

  PMID: 31339533 DERIVED

MeSH Terms

Conditions

Accidental Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Individuals will complete the bleeding control basic (B-Con) course followed by evaluation of individuals ability to apply each of 5 different types of tourniquets. Each individual is evaluated for all 5 types of tourniquets. The order of testing for tourniquets for each individual is randomized.

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 29, 2018
• Study Start: April 4, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 15, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)