Education, MedicalNCT01972698
Focused Cardiac and Lung Ultrasound in Anesthesia/Critical Care - The Role of Self-directed Simulation-assisted Training Compared to a Traditional Supervised Approach
A study testing Self-directed and simulation-assisted training and Traditional apprenticeship training in people with Education, Medical and Critical Care Ultrasonography, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a self-directed and simulation-based lung ultrasound (LUS) and focused cardiac ultrasound (FCU) curriculum is efficacious on anesthesia trainees' image acquisition skills and diagnostic acumen. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Critical Care Ultrasonography
- What is being tested?
- Self-directed and simulation-assisted training and Traditional apprenticeship training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
- PGY1 and PGY2 anesthesia resident at the University of Toronto
Who cannot join
- Previous training in lung ultrasound or FCU
Trial locations and contacts
1 site in 1 country.
Simon Abrahamson, MD contact
Alberto Goffi, MD contact
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Simon Abrahamson, MD, abrahamsons@smh.ca
Simon Abrahamson, MD
About this study
The purpose of this study is to determine whether a self-directed and simulation-based lung ultrasound (LUS) and focused cardiac ultrasound (FCU) curriculum is efficacious on anesthesia trainees' image acquisition skills and diagnostic acumen. The investigators hypothesize that a self-directed and ultrasound-assisted LUS and FCU curriculum that includes video lectures, online teaching modules, an ultrasound simulator, and self-directed hands-on sessions on critically ill mechanically ventilated patients is effective in training novice ultrasonographers to obtain good quality images, to correctly interpret them, and to support clinical decision-making in critically ill patients.
Trainees will be randomized to fully supervised FCU hands-on sessions on healthy models and critically ill mechanically ventilated patients (control group - traditional apprenticeship model) or to a completely self-directed and simulation-based approach (intervention group).
To assess if this new self-directed and simulation-based ultrasound curriculum leads to adequate acquisition of competences (adequate image acquisition and interpretation) in novice ultrasonographers, trainees will have to perform a focused lung and cardiac assessment on a critically ill mechanically ventilated patient.
- Conditions
- Education, Medical, Critical Care Ultrasonography
- Being tested
- Self-directed and simulation-assisted training, Traditional apprenticeship training
- Keywords
- Focused Cardiac Ultrasound, Lung Ultrasound, Simulation, Education, Web-based learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-directed and simulation-assisted trainingOther
All participants will attend an ultrasound introductory course (lectures and illustrative interactive cases).
Participants randomized to the intervention group will undergo a completely self-directed lung and focused cardiac ultrasound curriculum.
- A set of video-lectures on how to perform US on a critically ill patient (video-tutorials on image acquisition, troubleshooting, and pitfalls) will be provided.
- Participant will have access to an ultrasound simulator.
- Finally, participants in the intervention group will be asked to perform self-directed lung and focused cardiac ultrasound examinations on critically ill patients.
An investigator will supervise the sessions but will not interfere with the self-learning process.
- To support their learning, trainees will have access to on-line virtual FCU and LUS modules created by the Toronto General Hospital Department of Anesthesia Perioperative Interactive Education (http://pie.med.utoronto.ca/TTE/index.htm).
Traditional apprenticeship trainingOther
All participants will attend an half-day ultrasound introductory course.
- Participants randomized to the conventional group will initially attend 2-hour hands-on session on healthy volunteers, fully supervised by an expert critical care ultrasonographer (acquisition of basic knowledge with US machine settings and probe positioning and orientation, normal view acquisition, and identification of normal anatomical structures and landmarks).
- Subsequently, participants will attend a 3-hours hands-on session on critically ill patients, fully supervised by an expert critical care ultrasonographer.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed and simulation-assisted training | Experimental | Not described Receives: Other: Self-directed and simulation-assisted training |
| Traditional apprenticeship training | Active comparator | Not described Receives: Other: Traditional apprenticeship training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between pre- and post-intervention image acquisition and interpretation skill (as compared to the benchmark exam).
The quality of the images will be scored from 1 (worst) to 5 (best). The score will be based on the assessment of the quality of the image as well as an assessment of relevant cardiac structures included in each view.
Difference between pre- and post-intervention image acquisition skills and knowledge as measured by:
- Scanning time (total and per view)
- Anatomy recognition
- Items completion (%)
- Image interpretation (Y/N for lung sliding, interstitial syndrome, pleural effusion, consolidation, pericardial fluid, LV global function, RV global function, intravascular volume assessment; total and per objective accuracy)
- MCQs results (%) (Indication \& Image interpretation assessment)
- Video-interpretation of cases results (%) (Image interpretation \& Clinical decision-making assessment)
- Qualitative and quantitative analysis of survey results (dichotomic questions; graded criteria; e.g.10-point Likert scale)
Measured: ~4-5 months post-study enrolment, after completion of ultrasound training
Secondary outcomes (1)
Differences between self-directed and simulation-assisted training and traditional apprenticeship training
Difference between groups in image acquisition skills and knowledge as measured by:
- Quality of images obtained (total and per view score)
- Scanning time (total and per view)
- Anatomy recognition (at least 4 structures identified/views for FCU, and 3 structures identified/LUS findings for LUS; max score 20 + 6)
- Items completion (%)
- Image interpretation (Y/N for lung sliding, interstitial syndrome, pleural effusion, consolidation, pericardial fluid, LV global function, RV global function, intravascular volume assessment; total and per objective accuracy)
- MCQs results (%) (Indication \& Image interpretation assessment)
- Video-interpretation of cases results (%) (Image interpretation \& Clinical decision-making assessment)
- Qualitative and quantitative analysis of survey results (dichotomic questions; graded criteria; e.g.10-point Likert scale)
Measured: ~4-5 months post-study enrolment, after completion of ultrasound training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startNov 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Abrahamson, MD, Principal investigator, Unity Health TorontoHan Kim, MD, Principal investigator, Unity Health TorontoAlberto Goffi, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972698
- Sponsor's protocol ID
- CCUS-Toronto01
- Status last verified
- Dec 2016
- First submitted
- 24 Oct 2013
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Royse CF, Canty DJ, Faris J, Haji DL, Veltman M, Royse A. Core review: physician-performed ultrasound: the time has come for routine use in acute care medicine. Anesth Analg. 2012 Nov;115(5):1007-28. doi: 10.1213/ANE.0b013e31826a79c1. Epub 2012 Sep 25.
PubMed 23011559Labovitz AJ, Noble VE, Bierig M, Goldstein SA, Jones R, Kort S, Porter TR, Spencer KT, Tayal VS, Wei K. Focused cardiac ultrasound in the emergent setting: a consensus statement of the American Society of Echocardiography and American College of Emergency Physicians. J Am Soc Echocardiogr. 2010 Dec;23(12):1225-30. doi: 10.1016/j.echo.2010.10.005.
PubMed 21111923Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available.
PubMed 23711341Expert Round Table on Ultrasound in ICU. International expert statement on training standards for critical care ultrasonography. Intensive Care Med. 2011 Jul;37(7):1077-83. doi: 10.1007/s00134-011-2246-9. Epub 2011 May 26.
PubMed 21614639Mayo PH, Beaulieu Y, Doelken P, Feller-Kopman D, Harrod C, Kaplan A, Oropello J, Vieillard-Baron A, Axler O, Lichtenstein D, Maury E, Slama M, Vignon P. American College of Chest Physicians/La Societe de Reanimation de Langue Francaise statement on competence in critical care ultrasonography. Chest. 2009 Apr;135(4):1050-1060. doi: 10.1378/chest.08-2305. Epub 2009 Feb 2.
PubMed 19188546Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
PubMed 22392031Schmidt GA. ICU ultrasound. The coming boom. Chest. 2009 Jun;135(6):1407-1408. doi: 10.1378/chest.09-0502. No abstract available.
PubMed 19497889Neelankavil J, Howard-Quijano K, Hsieh TC, Ramsingh D, Scovotti JC, Chua JH, Ho JK, Mahajan A. Transthoracic echocardiography simulation is an efficient method to train anesthesiologists in basic transthoracic echocardiography skills. Anesth Analg. 2012 Nov;115(5):1042-51. doi: 10.1213/ANE.0b013e318265408f. Epub 2012 Jul 19.
PubMed 22822190
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Cardiac and Lung Ultrasound in Anesthesia/Critical Care - The Role of Self-directed Simulation-assisted Training Compared to a Traditional Supervised Approach
- ClinicalTrials.gov ID
- NCT01972698
- Acronym / sponsor ID
- CCUS-Toronto01
- Conditions
- Education, Medical, Critical Care Ultrasonography
- Keywords
- Focused Cardiac Ultrasound, Lung Ultrasound, Simulation, Education, Web-based learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 30 Oct 2013 (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.
The purpose of this study is to determine whether a self-directed and simulation-based lung ultrasound (LUS) and focused cardiac ultrasound (FCU) curriculum is efficacious on anesthesia trainees' image acquisition skills and diagnostic acumen. The investigators hypothesize that a self-directed and ultrasound-assisted LUS and FCU curriculum that includes video lectures, online teaching modules, an ultrasound simulator, and self-directed hands-on sessions on critically ill mechanically ventilated patients is effective in training novice ultrasonographers to obtain good quality images, to correctly interpret them, and to support clinical decision-making in critically ill patients.
Trainees will be randomized to fully supervised FCU hands-on sessions on healthy models and critically ill mechanically ventilated patients (control group - traditional apprenticeship model) or to a completely self-directed and simulation-based approach (intervention group).
To assess if this new self-directed and simulation-based ultrasound curriculum leads to adequate acquisition of competences (adequate image acquisition and interpretation) in novice ultrasonographers, trainees will have to perform a focused lung and cardiac assessment on a critically ill mechanically ventilated patient.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-directed and simulation-assisted training | Experimental | Other: Self-directed and simulation-assisted training |
| Traditional apprenticeship training | Active comparator | Other: Traditional apprenticeship training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PGY1 and PGY2 anesthesia resident at the University of Toronto
Key exclusion criteria (1 listed)
- Previous training in lung ultrasound or FCU
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 |
|---|---|---|
| Self-directed and simulation-assisted trainingAll participants will attend an ultrasound introductory course (lectures and illustrative interactive cases). Participants randomized to the intervention group will undergo a completely self-directed lung and focused cardiac ultrasound curriculum. * A set of video-lectures on how to perform US on a critically ill patient (video-tutorials on image acquisition, troubleshooting, and pitfalls) will be provided. * Participant will have access to an ultrasound simulator. * Finally, participants in the intervention group will be asked to perform self-directed lung and focused cardiac ultrasound examinations on critically ill patients. An investigator will supervise the sessions but will not interfere with the self-learning process. - To support their learning, trainees will have access to on-line virtual FCU and LUS modules created by the Toronto General Hospital Department of Anesthesia Perioperative Interactive Education (http://pie.med.utoronto.ca/TTE/index.htm). | Other | Self-directed and simulation-assisted training |
| Traditional apprenticeship trainingAll participants will attend an half-day ultrasound introductory course. * Participants randomized to the conventional group will initially attend 2-hour hands-on session on healthy volunteers, fully supervised by an expert critical care ultrasonographer (acquisition of basic knowledge with US machine settings and probe positioning and orientation, normal view acquisition, and identification of normal anatomical structures and landmarks). * Subsequently, participants will attend a 3-hours hands-on session on critically ill patients, fully supervised by an expert critical care ultrasonographer. | Other | Traditional apprenticeship training |
Primary outcome
Difference between pre- and post-intervention image acquisition and interpretation skill (as compared to the benchmark exam).
Time frame: ~4-5 months post-study enrolment, after completion of ultrasound training
The quality of the images will be scored from 1 (worst) to 5 (best). The score will be based on the assessment of the quality of the image as well as an assessment of relevant cardiac structures included in each view. Difference between pre- and post-intervention image acquisition skills and knowledge as measured by: * Scanning time (total and per view) * Anatomy recognition * Items completion (%) * Image interpretation (Y/N for lung sliding, interstitial syndrome, pleural effusion, consolidation, pericardial fluid, LV global function, RV global function, intravascular volume assessment; total and per objective accuracy) * MCQs results (%) (Indication \& Image interpretation assessment) * Video-interpretation of cases results (%) (Image interpretation \& Clinical decision-making assessment) * Qualitative and quantitative analysis of survey results (dichotomic questions; graded criteria; e.g.10-point Likert scale)
1 secondary outcome
Differences between self-directed and simulation-assisted training and traditional apprenticeship training
Time frame: ~4-5 months post-study enrolment, after completion of ultrasound training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 23011559Royse CF, Canty DJ, Faris J, Haji DL, Veltman M, Royse A. Core review: physician-performed ultrasound: the time has come for routine use in acute care medicine. Anesth Analg. 2012 Nov;115(5):1007-28. doi: 10.1213/ANE.0b013e31826a79c1. Epub 2012 Sep 25.
- Background: PubMed 21111923Labovitz AJ, Noble VE, Bierig M, Goldstein SA, Jones R, Kort S, Porter TR, Spencer KT, Tayal VS, Wei K. Focused cardiac ultrasound in the emergent setting: a consensus statement of the American Society of Echocardiography and American College of Emergency Physicians. J Am Soc Echocardiogr. 2010 Dec;23(12):1225-30. doi: 10.1016/j.echo.2010.10.005.
- Background: PubMed 23711341Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available.
- Background: PubMed 21614639Expert Round Table on Ultrasound in ICU. International expert statement on training standards for critical care ultrasonography. Intensive Care Med. 2011 Jul;37(7):1077-83. doi: 10.1007/s00134-011-2246-9. Epub 2011 May 26.
- Background: PubMed 19188546Mayo PH, Beaulieu Y, Doelken P, Feller-Kopman D, Harrod C, Kaplan A, Oropello J, Vieillard-Baron A, Axler O, Lichtenstein D, Maury E, Slama M, Vignon P. American College of Chest Physicians/La Societe de Reanimation de Langue Francaise statement on competence in critical care ultrasonography. Chest. 2009 Apr;135(4):1050-1060. doi: 10.1378/chest.08-2305. Epub 2009 Feb 2.
- Background: PubMed 22392031Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.
- Background: PubMed 19497889Schmidt GA. ICU ultrasound. The coming boom. Chest. 2009 Jun;135(6):1407-1408. doi: 10.1378/chest.09-0502. No abstract available.
- Background: PubMed 22822190Neelankavil J, Howard-Quijano K, Hsieh TC, Ramsingh D, Scovotti JC, Chua JH, Ho JK, Mahajan A. Transthoracic echocardiography simulation is an efficient method to train anesthesiologists in basic transthoracic echocardiography skills. Anesth Analg. 2012 Nov;115(5):1042-51. doi: 10.1213/ANE.0b013e318265408f. Epub 2012 Jul 19.
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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.
Simon Abrahamson, MD contact
Alberto Goffi, MD contact
Simon Abrahamson, MD principal investigator
Unity Health Toronto
Han Kim, MD principal investigator
Unity Health Toronto
Alberto Goffi, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-directed and simulation-assisted training and Traditional apprenticeship training in people with Education, Medical and Critical Care Ultrasonography, run by Unity Health Toronto at 1 site in Canada.
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 6 Dec 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 Canada. 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 Simon Abrahamson, MD (abrahamsons@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between pre- and post-intervention image acquisition and interpretation skill (as compared to the benchmark exam). (time frame: ~4-5 months post-study enrolment, after completion of ultrasound training). 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 NCT01972698, which also lists 8 linked publications.
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 6 Dec 2016.