AnesthesiaNCT06511466
Belmont Rapid Infuser Education
An observational study of Anesthesia, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
The Belmont Rapid Infuser (BRI) represents medical equipment with potential to elicit serious injury. The device is used infrequently and at irregular time of day which makes training and competency of operation difficult to ensure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jun 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anesthesia Faculty, Fellows and CRNA's
Study participants for phase 1 will include subjects in each of following categories: faculty, certified registered nurse anesthetists (CRNA), Registered Nurses and pediatric anesthesia fellows. Participants will be recruited from the Department of Anesthesia with no attention to gender, race, age, or socioeconomic status. -
About this study
Official title: Evaluation of a Training Model for the Proficient Use of the Belmont Rapid Infuser
The Belmont Rapid Infuser (BRI) represents medical equipment with potential to elicit serious injury. The device is used infrequently and at irregular time of day which makes training and competency of operation difficult to ensure. In the investigators institution BRI is used infrequently, usually for pediatric trauma cases and liver transplant cases.
The current teaching module for BRI includes oral slide presentation and live demonstration of BRI assembly and a written test. The effectiveness of this module has never been tested. The investigators central hypothesis is that modified training will significantly increase proficiency rate. The current traditional teaching module is insufficient to retain knowledge and be proficient. The investigators plan to study the current teaching module (traditional test method) to evaluate its effectiveness in acquisition of proficiency and retention of knowledge and skills.
Read more
The aims of this study are:
Aim 1. To evaluate the current method of teaching on proficient use of the BRI, Hypothesis: The use of traditional test method is not effective as less than 50% will pass in the first attempt.
Aim 2. Re-design the teaching module if necessary to optimize the method if the current method is found to be inadequate Hypothesis: Restructured test that provides a hand-on training as opposed to only an oral presentation with the traditional test will be associated with a higher pass rate (>80%).
Aim 3. To perform the success with BRI assembly in clinician pairs versus a single clinician.
Hypothesis: Working in pairs is better than working as a single person in setting up the BRI within the recommended time limit.
Aim 4: To better define proficiency with the use of the BRI with respect to retention of knowledge and skills after initial teaching and successful tests.
Hypothesis: Retention at 3 months is required irrespective of the initial training method in order to retain competency. Retention at 3 months will be higher with the restructured training than with the traditional training method.
The investigators will employ a quality improvement methodology invoking a PDSA (Plan-Do-Study Act) ramp to evaluate and improve the training model as necessary.
JHACO requires that all equipment users be trained annually in proper operating procedures for the equipment they use and that the training is documented. The investigators propose that retraining may have to be done more frequently in order to retain knowledge especially when this knowledge is to be used during emergency care of children.
Medical equipment in the OR may be divided into 4 categories based on the frequency of use and risk of injury. BRI belongs to the category of low frequency of use, but high risk of injury. These categories of medical equipment will require different strategies for teaching and training that need to be explored.
If the investigators current teaching module is found to be an effective one, it could be replicated for other types of medical equipment as well as spread to other institutions that use similar equipment.
Read the detailed description
This study is a randomized non-blinded study. Since the investigators are following a quality improvement methodology, there is only an intervention group and not a control group. All participants will receive the training intervention.
Study participants for phase 1 will include subjects in each of following categories: faculty, certified registered nurse anesthetists (CRNA), Registered Nurses and pediatric anesthesia fellows. Participants will be recruited from the Department of Anesthesia with no attention to gender, race, age, or socioeconomic status.
Participants will be tested with the traditional test method as a first step. Based on the outcomes of this test method, a decision would be made to conduct the restructured training. Traditional method is the current method used which involves oral slide presentation followed by demonstration and written test. There will be a video presentation followed by a demonstration by and experienced Anesthesia Tech Restructured training that the investigators are proposing will consist of an oral slide presentation and will follow hands-on assembly and written test. The 'hands-on assembly' will be the new training technique that will be different from the original technique.
- Conditions
- Anesthesia
- Keywords
- Education
What is being measured
The primary outcome is the main question the study is designed to answer.
Proficiency
Primary outcome: proficiency: composite score of pass - pass on BRI assembly and pass on knowledge test.
Measured: July 2013
Secondary outcomes (1)
Retention
Retention of proficiency at 3 months after delivery of the effective teaching module.
Measured: June 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511466
- Sponsor's protocol ID
- BRI
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2013
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Training Model for the Proficient Use of the Belmont Rapid Infuser
- ClinicalTrials.gov ID
- NCT06511466
- Acronym / sponsor ID
- BRI
- Conditions
- Anesthesia
- Keywords
- Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 22 Jul 2024 (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.
The Belmont Rapid Infuser (BRI) represents medical equipment with potential to elicit serious injury. The device is used infrequently and at irregular time of day which makes training and competency of operation difficult to ensure. In the investigators institution BRI is used infrequently, usually for pediatric trauma cases and liver transplant cases.
The current teaching module for BRI includes oral slide presentation and live demonstration of BRI assembly and a written test. The effectiveness of this module has never been tested. The investigators central hypothesis is that modified training will significantly increase proficiency rate. The current traditional teaching module is insufficient to retain knowledge and be proficient. The investigators plan to study the current teaching module (traditional test method) to evaluate its effectiveness in acquisition of proficiency and retention of knowledge and skills.
The aims of this study are:
Aim 1. To evaluate the current method of teaching on proficient use of the BRI, Hypothesis: The use of traditional test method is not effective as less than 50% will pass in the first attempt.
Aim 2. Re-design the teaching module if necessary to optimize the method if the current method is found to be inadequate Hypothesis: Restructured test that provides a hand-on training as opposed to only an oral presentation with the traditional test will be associated with a higher pass rate (>80%).
Aim 3. To perform the success with BRI assembly in clinician pairs versus a single clinician.
Hypothesis: Working in pairs is better than working as a single person in setting up the BRI within the recommended time limit.
Aim 4: To better define proficiency with the use of the BRI with respect to retention of knowledge and skills after initial teaching and successful tests.
Hypothesis: Retention at 3 months is required irrespective of the initial training method in order to retain competency. Retention at 3 months will be higher with the restructured training than with the traditional training method.
The investigators will employ a quality improvement methodology invoking a PDSA (Plan-Do-Study Act) ramp to evaluate and improve the training model as necessary.
JHACO requires that all equipment users be trained annually in proper operating procedures for the equipment they use and that the training is documented. The investigators propose that retraining may have to be done more frequently in order to retain knowledge especially when this knowledge is to be used during emergency care of children.
Medical equipment in the OR may be divided into 4 categories based on the frequency of use and risk of injury. BRI belongs to the category of low frequency of use, but high risk of injury. These categories of medical equipment will require different strategies for teaching and training that need to be explored.
If the investigators current teaching module is found to be an effective one, it could be replicated for other types of medical equipment as well as spread to other institutions that use similar equipment.
Detailed description
This study is a randomized non-blinded study. Since the investigators are following a quality improvement methodology, there is only an intervention group and not a control group. All participants will receive the training intervention.
Study participants for phase 1 will include subjects in each of following categories: faculty, certified registered nurse anesthetists (CRNA), Registered Nurses and pediatric anesthesia fellows. Participants will be recruited from the Department of Anesthesia with no attention to gender, race, age, or socioeconomic status.
Participants will be tested with the traditional test method as a first step. Based on the outcomes of this test method, a decision would be made to conduct the restructured training. Traditional method is the current method used which involves oral slide presentation followed by demonstration and written test. There will be a video presentation followed by a demonstration by and experienced Anesthesia Tech Restructured training that the investigators are proposing will consist of an oral slide presentation and will follow hands-on assembly and written test. The 'hands-on assembly' will be the new training technique that will be different from the original technique.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesia Faculty, Fellows and CRNA's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proficiency
Time frame: July 2013
Primary outcome: proficiency: composite score of pass - pass on BRI assembly and pass on knowledge test.
1 secondary outcome
Retention
Time frame: June 2014
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 22 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Proficiency (time frame: July 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2024.