EchocardiographyLCCUSUMLVEFNCT02866318
Learning Curve CUSUM of LV Ejection Fraction by Visual Estimation in Novice Practitioners
An observational study of Echocardiography, run by Hanyang University at 1 site in South Korea.
Trial summary
This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Echocardiography
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Dec 2016
- 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: Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file.
Who may be able to join
- EM residents who have no experience of echocardiography
Who cannot join
- They do not want to participate this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
YOONJE LEE, M.D., +82-31-560-2053, yong0831@naver.com
YOONJE LEE, M.D.
About this study
Official title: CUSUM Analysis in the Assessment of Novice Practitioners' Visual Estimation in LV Ejection Fraction With Echocardiographic Images
This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital.
Read the detailed description
Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file. They received echocardiography interpretation skill training which included one hour of lecture. Twenty echocardiography videos files were provided during training session, they were instructed how to estimate EF by looking at the LV contractility without taking any measurement.
This procedure took less than 2 minutes in each case. An evaluation form was completed by each EP. EF is estimated qualitatively (Normal / Global hypokinesia), RWMA and quantitatively (%) by EP with echocardiographic certification(cardiologist). An each echocardiography has been performed with M7R® model ultrasound machine was reported by experienced echocardiographers as using MSM. The echocardiography results were reported blinded to our study.
A participant estimated the EF based on a complete assessment of LV wall motion including parasternal long-axis, short-axis, and apical four chamber view except for MSM.
And, participants wrote down EF(%) and a region of WMA as visual assessment and checked Normal wall motion or Global hypokinesia in EF reporting paper.
- Conditions
- Echocardiography
- Being tested
- Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Novice practitioners | Residents in Emergency department who has no experiences of echocardiography prior to the study. Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning curve
Rate of concordance
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YOON-JE, Hanyang University
- Investigators
- YOONJE LEE, M.D., Principal investigator, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866318
- Sponsor's protocol ID
- LCCUSUMchallenge1
- Acronym
- LCCUSUMLVEF
- Status last verified
- Aug 2016
- First submitted
- 8 Mar 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CUSUM Analysis in the Assessment of Novice Practitioners' Visual Estimation in LV Ejection Fraction With Echocardiographic Images
- ClinicalTrials.gov ID
- NCT02866318
- Acronym / sponsor ID
- LCCUSUMLVEF / LCCUSUMchallenge1
- Conditions
- Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Aug 2016 (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.
This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital.
Detailed description
Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file. They received echocardiography interpretation skill training which included one hour of lecture. Twenty echocardiography videos files were provided during training session, they were instructed how to estimate EF by looking at the LV contractility without taking any measurement.
This procedure took less than 2 minutes in each case. An evaluation form was completed by each EP. EF is estimated qualitatively (Normal / Global hypokinesia), RWMA and quantitatively (%) by EP with echocardiographic certification(cardiologist). An each echocardiography has been performed with M7R® model ultrasound machine was reported by experienced echocardiographers as using MSM. The echocardiography results were reported blinded to our study.
A participant estimated the EF based on a complete assessment of LV wall motion including parasternal long-axis, short-axis, and apical four chamber view except for MSM.
And, participants wrote down EF(%) and a region of WMA as visual assessment and checked Normal wall motion or Global hypokinesia in EF reporting paper.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novice practitioners | – | Device: EchocardiographyResidents in Emergency department who has no experiences of echocardiography prior to the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file.
Key inclusion criteria (1 listed)
- EM residents who have no experience of echocardiography
Key exclusion criteria (1 listed)
- They do not want to participate this study
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 |
|---|---|---|
| Echocardiography | Device | Novice practitioners |
Primary outcome
Learning curve
Time frame: 2 hours
Rate of concordance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
YOONJE LEE, M.D. principal investigator
Hanyang University Guri Hospital
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 Echocardiography, run by Hanyang University at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 15 Aug 2016. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YOONJE LEE, M.D. (+82-31_560-2053, yong0831@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning curve (time frame: 2 hours). 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 15 Aug 2016.