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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01972698
Other study ID # CCUS-Toronto01
Secondary ID
Status Recruiting
Phase N/A
First received October 24, 2013
Last updated December 5, 2016
Start date November 2014
Est. completion date June 2018

Study information

Verified date December 2016
Source St. Michael's Hospital, Toronto
Contact Simon Abrahamson, MD
Email abrahamsons@smh.ca
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- PGY1 and PGY2 anesthesia resident at the University of Toronto

Exclusion Criteria:

- Previous training in lung ultrasound or FCU

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Self-directed and simulation-assisted training
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 training
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.

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Expert 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. — View Citation

Labovitz 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. — View Citation

Mayo 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 Société de Réanimation de Langue Française statement on competence in critical care ultrasonography. Chest. 2009 Apr;135(4):1050-60. doi: 10.1378/chest.08-2305. — View Citation

Neelankavil 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. — View Citation

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. Review. — View Citation

Schmidt GA. ICU ultrasound. The coming boom. Chest. 2009 Jun;135(6):1407-8. doi: 10.1378/chest.09-0502. — View Citation

Spencer 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. — View Citation

Volpicelli 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of baseline visuo-spatial skill Visuo-spatial skill test scores compared to FCU outcomes related to technical proficiency gained (quality of images acquired; percent correct views obtained; scanning time; anatomy recognition). ~4-5 months post-study enrolment, after completion of ultrasound training No
Other Knowledge and skills retention at 3 months Difference between groups in image acquisition skill 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)
~4-5 months post-study enrolment, after completion of ultrasound training No
Primary 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)
~4-5 months post-study enrolment, after completion of ultrasound training No
Secondary 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)
~4-5 months post-study enrolment, after completion of ultrasound training No
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