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Completed

NCT Number: NCT04293211

Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control Course in Regards to Proper Tourniquet Placement Amongst School Personnel

This is a joint project by the White Plains School District and White Plains Hospital regarding the training of over 66 school personnel regarding the American College of Surgeons (ACS) "Stop the Bleed" campaign for mass casualty incidents. This project developed from an outreach from White Plains Hospital and an interest from the White Plains School District to work together to train staff in the event of a mass casualty incident / active shooter.

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Key information

Conditions

Tourniquet Placement Wound Packing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

White Plains Hospital

White Plains, New York, 10601, United States

About this study

From January through June 2019, participants will be requested to attend one of six sessions that will be held at the hospital simulation center. Participants will be randomized into 1 of 2 study arms. Each participant that enters the B-Con course will be randomized using a "random generator." At the start of the program, all participants will be explained the purpose of the research study and the two groups (Control versus High Fidelity). An option will be given for participants to be able to opt out. So that our participants all have the same opportunities afforded to their colleagues, we will also offer the control group the option to participate in the high fidelity simulation at the conclusion of the entire program.

All groups will sit through the exact same B-Con powerpoint presentation by trained STB instructors. This course includes the powerpoint presentation that reviews how to call for help, assess those affected, identify the location of life-threatening bleed, apply pressure, pack a wound and/or apply a tourniquet and when to do this. Tourniquet placement is taught as is wound packing placement. Participants will each be given tourniquets to practice alongside the instructor. The presentation will cover the first hour of the curriculum. This is considered to be the standard for this course.

Upon conclusion of the course, the control group and high fidelity group will be separated into two rooms based on their randomization. In groups of 2, participants will be trained in tourniquet placement, wound packing. The High Fidelity group will have a simulation intervention in addition and the wound packing will be performed on a device that has biofeedback. Upon conclusion of this one hour session, both groups will be tested on wound packing and tourniquet placement. They will again be tested 3-8 months later on retention for wound packing and tourniquet placement.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any volunteer employee who is over the age of 18 that is a staff member at the White Plains School District.

Exclusion criteria

  • any participants who have prior hemorrhage control training. However, although excluded from the study, they are welcome to participate in the program

Treatment and study plan

simulation

Other

To measure the efficacy of adding a high-fidelity simulation versus low fidelity simulation to the current B-Con Course. This will be assessed by evaluation of applying tourniquets properly and packing traumatic wounds as well as retention of these skills over a period of time amongst school teachers and security personnel.

Primary outcomes

  1. Assessment by Evaluation of Applying Tourniquets

    Time frame: 6 months

    Measure correct tourniquet placement based on internally validated scale. Binomial variable (correct or incorrect). Indications for incorrect placement will also be documented (too loose, incorrect location, longer than 7 minutes, participant requested to discontinue).

Secondary outcomes

  1. Assessment by Evaluation of Packing Traumatic Wounds

    Time frame: 6 months

    Amount of pressure placed for 90 seconds using a biofeedback device with a threshold of 25psi based on prior studies on hemorrhage control on porcine models

  2. Retention of Skills Over a Period of Time

    Time frame: 8 months

    Tourniquet and wound packing based on above rubric and biofeedback device, 3-8 months after training

  3. Evaluate the Change in Length of Time to Tourniquet Placement with Simulation Scenario

    Time frame: 6 months

    Measure correct tourniquet placement based on internally validated scale. Binomial variable (correct or incorrect). Indications for incorrect placement will also be documented (too loose, incorrect location, longer than 7 minutes, participant requested to discontinue).

Sponsors and collaborators

Lead sponsor

White Plains Hospital

Other

Registry information

Official study title

Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2020
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.