Tourniquet PlacementNCT04293211
Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control Course in Regards to Proper Tourniquet Placement Amongst School Personnel
An observational study of Tourniquet Placement and Wound Packing, run by White Plains Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourniquet Placement, Wound Packing
- What is being tested?
- Simulation
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2019to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: White Plains School District employees
Who may be able to join
- any volunteer employee who is over the age of 18 that is a staff member at the White Plains School District.
Who cannot join
- any participants who have prior hemorrhage control training. However, although excluded from the study, they are welcome to participate in the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control
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.
Read the detailed description
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.
- Conditions
- Tourniquet Placement, Wound Packing
- Being tested
- Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Upon completion of B-Con presentation, this group will be tested regarding tourniquet placement using the rubric. A tourniquet is regarded as appropriately placed if it is 2 inches above the wound, not located on a joint, appropriate tightness (meaning a finger cannot be placed under it and it is indenting the mannequin). This is as per prior studies. Feedback will be given at the end of this session. | |
| Simulation | This group will have to interact with a panicked actor/actress as well as the SIM MAN 3G who will have two wounds under his clothes. One that will be actively pumping a large amount of arterial blood that will require tourniquet placement and the other wound with trace venous bleeding that will require simple pressure with a clean cloth. Participants will be given feedback on items that they missed. The observer will fill out the rubric and give feedback to the group. Receives: Other: Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment by Evaluation of Applying Tourniquets
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).
Measured: 6 months
Secondary outcomes (3)
Assessment by Evaluation of Packing Traumatic Wounds
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
Measured: 6 months
Retention of Skills Over a Period of Time
Tourniquet and wound packing based on above rubric and biofeedback device, 3-8 months after training
Measured: 8 months
Evaluate the Change in Length of Time to Tourniquet Placement with Simulation Scenario
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start19 Jan 2019
- Primary completion15 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourniquet PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- White Plains Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293211
- Sponsor's protocol ID
- Stop The Bleed
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jafri FN, Dadario NB, Kumar A, Silverstein SR, Quintero F, Larsen EA, Fasciglione K, Mirante D, Ellsworth K, Amicucci B, Ricca J. The Addition of High-Technology Into the Stop the Bleed Program Among School Personnel Improves Short-Term Skill Application, Not Long-Term Retention. Simul Healthc. 2021 Dec 1;16(6):e159-e167. doi: 10.1097/SIH.0000000000000546.
PubMed 33600137
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Adding High Fidelity Simulation to the Bleeding Control
- ClinicalTrials.gov ID
- NCT04293211
- Acronym / sponsor ID
- Stop The Bleed
- Conditions
- Tourniquet Placement, Wound Packing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- White Plains HospitalUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Upon completion of B-Con presentation, this group will be tested regarding tourniquet placement using the rubric. A tourniquet is regarded as appropriately placed if it is 2 inches above the wound, not located on a joint, appropriate tightness (meaning a finger cannot be placed under it and it is indenting the mannequin). This is as per prior studies. Feedback will be given at the end of this session. |
| Simulation | – | Other: SimulationThis group will have to interact with a panicked actor/actress as well as the SIM MAN 3G who will have two wounds under his clothes. One that will be actively pumping a large amount of arterial blood that will require tourniquet placement and the other wound with trace venous bleeding that will require simple pressure with a clean cloth. Participants will be given feedback on items that they missed. The observer will fill out the rubric and give feedback to the group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- White Plains School District employees
Key inclusion criteria (1 listed)
- any volunteer employee who is over the age of 18 that is a staff member at the White Plains School District.
Key exclusion criteria (1 listed)
- any participants who have prior hemorrhage control training. However, although excluded from the study, they are welcome to participate in the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulationTo 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. | Other | Simulation |
Primary outcome
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).
3 secondary outcomes
Assessment by Evaluation of Packing Traumatic Wounds
Time frame: 6 months
Retention of Skills Over a Period of Time
Time frame: 8 months
Evaluate the Change in Length of Time to Tourniquet Placement with Simulation Scenario
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 33600137Jafri FN, Dadario NB, Kumar A, Silverstein SR, Quintero F, Larsen EA, Fasciglione K, Mirante D, Ellsworth K, Amicucci B, Ricca J. The Addition of High-Technology Into the Stop the Bleed Program Among School Personnel Improves Short-Term Skill Application, Not Long-Term Retention. Simul Healthc. 2021 Dec 1;16(6):e159-e167. doi: 10.1097/SIH.0000000000000546.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourniquet Placement and Wound Packing, run by White Plains Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment by Evaluation of Applying Tourniquets (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.