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

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ClinicalTrials.gov Identifier: NCT01972698
Recruitment Status : Recruiting
First Posted : October 30, 2013
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment Phase
Education, Medical Critical Care Ultrasonography Other: Self-directed and simulation-assisted training Other: Traditional apprenticeship training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Study Start Date : November 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-directed and simulation-assisted training 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).


Active Comparator: Traditional apprenticeship training Other: 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]

    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)


Other Outcome Measures:
  1. Assessment of baseline visuo-spatial skill [ Time Frame: ~4-5 months post-study enrolment, after completion of ultrasound training ]
    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).

  2. Knowledge and skills retention at 3 months [ Time Frame: ~4-5 months post-study enrolment, after completion of ultrasound training ]

    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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PGY1 and PGY2 anesthesia resident at the University of Toronto

Exclusion Criteria:

  • Previous training in lung ultrasound or FCU

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972698


Contacts
Contact: Simon Abrahamson, MD abrahamsons@smh.ca
Contact: Alberto Goffi, MD alberto.goffi@uhn.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Simon Abrahamson, MD       abrahamsons@smh.ca   
Principal Investigator: Simon Abrahamson, MD         
Principal Investigator: Han Kim, MD         
Principal Investigator: Goffi Alberto, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Simon Abrahamson, MD St. Michael's Hospital, Toronto
Principal Investigator: Han Kim, MD St. Michael's Hospital, Toronto
Principal Investigator: Alberto Goffi, MD University Health Network, Toronto

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01972698     History of Changes
Other Study ID Numbers: CCUS-Toronto01
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by St. Michael's Hospital, Toronto:
Focused Cardiac Ultrasound
Lung Ultrasound
Simulation
Education
Web-based learning

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs