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

NCT03762863 | Completed FDA Device

• 1 other identifier: QMREC2206a
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Appropriate application of a CAT tourniquet

EXPERIMENTAL

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

Interventions

Tourniquet application skill retention DEVICE

Tourniquet application following the procedure as learned in the Stop the Bleed curriculum.

Also known as: Evaluation of retention of critical steps in tourniquet application 6 months after attending a Stop the Bleed class.

Appropriate application of a CAT tourniquet

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Less than 18 years of age
• Any participant that attends another program that includes tourniquet application skills after attendance at the Stop the Bleed program

Sponsors & Collaborators

• Somerville Office of Emergency Management: lead

Study Sites (1)

Somerville EMS Headquarters

Somerville, New Jersey, 08876, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 4, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: December 2019 through June 30 2019
• Access Criteria: email the investigator at sweinman@somervillenj.org

Locations

US (1)