Retention of Tourniquet Application Skills Following Participation in a Bleeding Control Course

Prospective, observational study of students 6 months after completing a Stop the Bleed course to determine overall ability to effectively use a tourniquet to stop external extremity hemorrhage. Following the release of the Hartford Consensus in October 2015, the American College of Surgeons Committee on Trauma initiated the National Stop the Bleed campaign (2) that among several proactive recommendations was to encourage first responders and the lay public to become trained, equipped and empowered to step forward and intervene in a bleeding emergency. The Stop the Bleed initiative provides baseline education and training in the use of tourniquets to stop extremity hemorrhage when pressure alone does not work. While the program has progressively provided education and training to over 130,000 individuals worldwide there are no recommendations regarding time intervals for refresher training to maintain confidence and competence in the use of tourniquets. The rationale for this study is to ascertain if tourniquet application skills are sufficiently maintained 6 months after participation in a Stop the Bleed course and to provide recommendations for refresher training based on the results.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: Tourniquet application skill retention

Detailed Description

In response to an alarming rise in active shooter/hostile incidents in the United States, in 2013 the American College of Surgeons convened a committee of multidisciplinary trauma experts who in collaboration with the federal government created a protocol for a national policy to enhance survivability from these active shooter incidents as well as other intentional mass casualty events. The committee's recommendations were called the Hartford Consensus. Among the recommendations of the Hartford Consensus was the training of first responders (law enforcement, EMS and fire personnel) as well as the public (so-called "immediate responders") in the basics of bleeding control. In October 2015, responding aforementioned recommendation, the White House launched the Stop the Bleed national awareness campaign as a "call to action". Under the auspices of the American College of Surgeons Committee on Trauma, a curriculum was developed teaching responders how to recognize and intervene in the event of catastrophic bleeding. Of the three bleeding control interventions promoted (external pressure, wound packing and tourniquet application) the tourniquet application component of the Stop the Bleed curriculum is evidence-based and provides the student with both didactic and psychomotor education. To date there is a paucity of data available to provide insight as to how long this vital skill is retained. More over there is no recommendation on refresher education with additional opportunities to practice this life-saving procedure. This study will serve as a follow-up to Stop the Bleed (also called Bleeding Control or B-Con) education provided by the investigator. The intent is to bring participants from a Bleeding Control course back to the investigator 6 months following initial education and assess their retention of tourniquet application skills. All participants will be assessed using a tourniquet simulator and their success will be measured in their ability to stop the bleeding using the simulator. The participants will be observed for proper identification of bleeding necessitating the use of a tourniquet, selection of the proper site of application, proper application of the device (use as described in the Stop the Bleed curriculum). This study will not involve the use of actual patients or human subjects. It is intended to be follow up assessment to skills-based education with an endpoint that will provide insight as to a time-frame for refresher training. Of the three bleeding control skills taught as part of the Stop the Bleed curriculum, the application the tourniquet is a universal stop the bleed intervention and most likely intervention to be used to stop the bleed.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerville, New Jersey, United States, 08876
      • Somerville EMS Headquarters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All adults (18 years of age and above) participating in an American College of Surgeons Sponsored "Stop the Bleed" course

Exclusion Criteria:

1. Less than 18 years of age
2. Any participant that attends another program that includes tourniquet application skills after attendance at the Stop the Bleed program
3. Any participant that does not consent for inclusion for study data collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Appropriate application of a CAT tourniquet; All study subjects attended an American College of Surgeons Stop the Bleed Basic course with live training by approved instructors. 6 months after participation in the Stop the Bleed class volunteers study subjects are randomly solicited to return for a refresher session. During this refresher session the volunteer study subjects are observed to determine if they have retained tourniquet application skills and to what degree they have retained them. A 10 point check list will be used to evaluated tourniquet application skill retention.

Device: Tourniquet application skill retention; Tourniquet application following the procedure as learned in the Stop the Bleed curriculum.; Other Names: Evaluation of retention of critical steps in tourniquet application 6 months after attending a Stop the Bleed class.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tourniquet application retention	A 10 point data collection checklist was developed paralleling the procedure for tourniquet application as set forth in the American College of Surgeons Committee on Trauma's Stop the Bleed curriculum. Each participant number will be assigned to each volunteer to maintain anonymity and for accounting purposes. Each participant will be isolated and observed by the investigator as he/she attempts to apply a tourniquet to a simulated leg amputation simulator (BCon Trainer, Techline Technologies, Willow Grove, PA). As the participant proceeds with the application of the tourniquet the observer will compare the steps in the tourniquet application process with the steps on data collection form noting any deviations ("YES" for correct, "NO" for deviation or failure to follow that step). Also noted will be total time to complete the tourniquet application process. The raw data from each form will be transferred to a master spread sheet for ease of data analysis.	6 months

Collaborators and Investigators

• Sponsor: Somerville Office of Emergency Management

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 22, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: QMREC2206a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All raw data and methodology will be shared upon study completion
• IPD Sharing Time Frame: December 2019 through June 30 2019
• IPD Sharing Access Criteria: email the investigator at sweinman@somervillenj.org
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No