NCT01972698

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

3.6 years

First QC Date

October 24, 2013

Last Update Submit

December 5, 2016

Conditions

Keywords

Focused Cardiac UltrasoundLung UltrasoundSimulationEducationWeb-based learning

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Differences between self-directed and simulation-assisted training and traditional apprenticeship training

    ~4-5 months post-study enrolment, after completion of ultrasound training

Other Outcomes (2)

  • Assessment of baseline visuo-spatial skill

    ~4-5 months post-study enrolment, after completion of ultrasound training

  • Knowledge and skills retention at 3 months

    ~4-5 months post-study enrolment, after completion of ultrasound training

Study Arms (2)

Self-directed and simulation-assisted training

EXPERIMENTAL
Other: Self-directed and simulation-assisted training

Traditional apprenticeship training

ACTIVE COMPARATOR
Other: Traditional apprenticeship training

Interventions

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).

Self-directed and simulation-assisted 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.

Traditional apprenticeship training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PGY1 and PGY2 anesthesia resident at the University of Toronto

You may not qualify if:

  • Previous training in lung ultrasound or FCU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (8)

  • 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.

    PMID: 23011559BACKGROUND
  • 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.

    PMID: 21111923BACKGROUND
  • 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. No abstract available.

    PMID: 23711341BACKGROUND
  • 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. Epub 2011 May 26.

    PMID: 21614639BACKGROUND
  • 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 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.

    PMID: 19188546BACKGROUND
  • 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. Epub 2012 Mar 6.

    PMID: 22392031BACKGROUND
  • Schmidt GA. ICU ultrasound. The coming boom. Chest. 2009 Jun;135(6):1407-1408. doi: 10.1378/chest.09-0502. No abstract available.

    PMID: 19497889BACKGROUND
  • 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. Epub 2012 Jul 19.

    PMID: 22822190BACKGROUND

Study Officials

  • Simon Abrahamson, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
  • Han Kim, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
  • Alberto Goffi, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Abrahamson, MD

CONTACT

Alberto Goffi, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 30, 2013

Study Start

November 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations