Focused Cardiac and Lung Ultrasound in Anesthesia/Critical Care - The Role of Self-directed Simulation-assisted Training Compared to a Traditional Supervised Approach

Education, Medical Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01972698
• Other study ID #: CCUS-Toronto01
• 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

• Critical Care Ultrasonography
• Education, Medical

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