Medical Students,Lung Ultrasound,Simulation TrainingNCT02152072
Using Simulation-Based Training to Incorporate Lung Ultrasound Into Physical Examination
An observational study of Medical Students,Lung Ultrasound,Simulation Training, run by Tulane University Health Sciences Center.
Trial summary
Dyspnea is a common symptom encountered frequently by medical practitioners. The differential diagnosis for a patient with such a symptom is broad and time consuming, while immediate management for distressed patients is what is desired. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Students,Lung Ultrasound,Simulation Training
- What is being tested?
- Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical Examination
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical Students
Who may be able to join
- Third year medical students who signed the consent
Who cannot join
- a medical student who is not a third year and/or didn't signed the consent
About this study
Dyspnea is a common symptom encountered frequently by medical practitioners. The differential diagnosis for a patient with such a symptom is broad and time consuming, while immediate management for distressed patients is what is desired. Lung ultrasound (LUS) is a relatively new technique that will help physicians more accurately diagnose and manage patients who present with dyspnea.
Focused medical ultrasonography education is becoming integrated into many physician residency training programs. Recent studies indicate a possible relationship between focused ultrasonography training in medical school curricula and improved physical examination accuracy. Thus, a short-term training program in LUS during medical school will have a major impact on physicians to be comfortable in using this skill when dealing with distressed patients in their prospective residency training. It will reduce educational burdens for physician residency programs and improve overall physician competency.
Read more
Simulation-based medical education (SBME) is ideally suited for offering effective training in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing with stressful clinical scenarios without exposing patients to any additional risk. SBME has also been shown to be a reliable tool for assessing learners' procedural skills and for teaching topics such as teamwork and communication.
The investigators hypothesize that simulation-based training of medical students will enable them to more effectively evaluate patients with shortness of breath using LUS.
- Being tested
- Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical ExaminationOther
| Study group | Role | What they receive |
|---|---|---|
| medical students | Not described Receives: Other: Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the pre and post-performance of medical students in using lung ultrasound (LUS) for patients with shortness of breath.
We designed the Thoracic Ultrasound Knowledge and Skills-Assessment Test (TUKSAT) which consists of questions about correctly identifying different organs using ultrasound (US) as well image acquisition skills as an objective measurement for students.
Study participants will receive simulation-based LUS training through a course provided by a physician experienced in LUS as two sessions at the first week of their medical clerkship. TUKSAT as a pre-evaluation measure will be given.
During the next 7 weeks, participants will be asked to see videos of LUS images where they will be asked to interpret the findings. A post-evaluation TUKSAT will then be given.
Measured: 8 weeks
Secondary outcomes (1)
Measure diagnostic agreement between trainees and experienced physicians in LUS following simulation-based medical education..
Following their simulation-based training, participants will have videos of LUS images where they will be asked to interpret the findings. Diagnostic agreement will be compared between trainees' LUS finding and experienced physicians.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2014
Why it stopped: No Participant Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Students,Lung Ultrasound,Simulation TrainingStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fayez Kheir,MD,MSc, Tulane University Health Sciences Center
- Investigators
- Fayez Kheir, MD,MSc, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152072
- Sponsor's protocol ID
- 609459-1
- Status last verified
- Apr 2018
- First submitted
- 22 May 2014
- Last updated
- 27 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Simulation-Based Training to Incorporate Lung Ultrasound Into Physical Examination
- ClinicalTrials.gov ID
- NCT02152072
- Acronym / sponsor ID
- 609459-1
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Participant Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tulane University Health Sciences CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- 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.
Dyspnea is a common symptom encountered frequently by medical practitioners. The differential diagnosis for a patient with such a symptom is broad and time consuming, while immediate management for distressed patients is what is desired. Lung ultrasound (LUS) is a relatively new technique that will help physicians more accurately diagnose and manage patients who present with dyspnea.
Focused medical ultrasonography education is becoming integrated into many physician residency training programs. Recent studies indicate a possible relationship between focused ultrasonography training in medical school curricula and improved physical examination accuracy. Thus, a short-term training program in LUS during medical school will have a major impact on physicians to be comfortable in using this skill when dealing with distressed patients in their prospective residency training. It will reduce educational burdens for physician residency programs and improve overall physician competency.
Simulation-based medical education (SBME) is ideally suited for offering effective training in a zero-risk environment. It enables trainees to gain knowledge and confidence in dealing with stressful clinical scenarios without exposing patients to any additional risk. SBME has also been shown to be a reliable tool for assessing learners' procedural skills and for teaching topics such as teamwork and communication.
The investigators hypothesize that simulation-based training of medical students will enable them to more effectively evaluate patients with shortness of breath using LUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical students | – | Other: Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical Examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Students
Key inclusion criteria (1 listed)
- Third year medical students who signed the consent
Key exclusion criteria (1 listed)
- a medical student who is not a third year and/or didn't signed the consent
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 |
|---|---|---|
| Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical Examination | Other | medical students |
Primary outcome
Assess the pre and post-performance of medical students in using lung ultrasound (LUS) for patients with shortness of breath.
Time frame: 8 weeks
We designed the Thoracic Ultrasound Knowledge and Skills-Assessment Test (TUKSAT) which consists of questions about correctly identifying different organs using ultrasound (US) as well image acquisition skills as an objective measurement for students. Study participants will receive simulation-based LUS training through a course provided by a physician experienced in LUS as two sessions at the first week of their medical clerkship. TUKSAT as a pre-evaluation measure will be given. During the next 7 weeks, participants will be asked to see videos of LUS images where they will be asked to interpret the findings. A post-evaluation TUKSAT will then be given.
1 secondary outcome
Measure diagnostic agreement between trainees and experienced physicians in LUS following simulation-based medical education..
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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.
Fayez Kheir, MD,MSc principal investigator
Tulane University
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Students,Lung Ultrasound,Simulation Training, run by Tulane University Health Sciences Center.
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: withdrawn, as of the sponsor's last update on 27 Apr 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assess the pre and post-performance of medical students in using lung ultrasound (LUS) for patients with shortness of breath. (time frame: 8 weeks). 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 27 Apr 2018.