- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01688271
Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion
A Prospective Study to Determine the Efficacy of Simulation-based Training on Practicing Anesthesiologists' Acquisition of Ultrasound-guided Perineural Catheter Insertion Skills
This study will determine the efficacy of a teaching program incorporating hybrid simulation in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral nerve block (CPNB).
This study will also examine the extent of practice change following participation in a regional anesthesia teaching program incorporating hybrid simulation. In addition, this study will assess remaining obstacles to incorporating the use of US-guided perineural catheters through identifying potential future interventions and "tool-kits" for setting up perineural catheter programs.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Anesthesiologists in practice ten years or more; active board certification (American Board of Anesthesiologists); active license to practice medicine in California; and willingness to spend one full day (8 hours) participating in the standardized workshop and undergo interval survey and interview follow-up for one year.
Exclusion Criteria:
- Formal training (e.g., post-graduate fellowship) in regional anesthesia; current practice includes the routine performance of US-guided PNB (≥10 blocks per month); or visual, hearing, or other communication impairment that would interfere with video recording or require substantial deviation from the standardized teaching curriculum.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Anesthesiologists
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in video assessment score from baseline
Time Frame: baseline (time 0), interval assessment (time 1), and post-course (time 2)
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The primary outcome is the change in composite score from baseline assessment based on the video analysis tool used by blinded reviewers.
The baseline assessment at time 0 will take place after initial orientation to the simulation lab.
This procedure will take approximately 15 min to perform and record.
After the morning session of training (4 hours), the interval assessment at time 1 will take place in the same manner.
The final assessment will take place following the entire course (8 hours total) according to the same procedures at time 2. Video recordings will be reviewed at a later date after completion of the training day.
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baseline (time 0), interval assessment (time 1), and post-course (time 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation of new training
Time Frame: Every 3 months post-training for 1 year
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Starting 3 months after the workshop and every 3 months thereafter for one year, subjects will be sent an online practice assessment survey similar to the pre-course survey by the research assistant and will be asked to report their case logs.
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Every 3 months post-training for 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward R Mariano, MD, MAS, VA Palo Alto Health Care System
Publications and helpful links
General Publications
- Sites BD, Spence BC, Gallagher JD, Wiley CW, Bertrand ML, Blike GT. Characterizing novice behavior associated with learning ultrasound-guided peripheral regional anesthesia. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):107-15. doi: 10.1016/j.rapm.2006.11.006.
- Ajmal M, Power S, Smith T, Shorten GD. Ergonomic task analysis of ultrasound-guided femoral nerve block: a pilot study. J Clin Anesth. 2011 Feb;23(1):35-41. doi: 10.1016/j.jclinane.2010.06.006.
- Ilfeld BM, Enneking FK. Continuous peripheral nerve blocks at home: a review. Anesth Analg. 2005 Jun;100(6):1822-1833. doi: 10.1213/01.ANE.0000151719.26785.86.
- Ilfeld BM, Gearen PF, Enneking FK, Berry LF, Spadoni EH, George SZ, Vandenborne K. Total knee arthroplasty as an overnight-stay procedure using continuous femoral nerve blocks at home: a prospective feasibility study. Anesth Analg. 2006 Jan;102(1):87-90. doi: 10.1213/01.ane.0000189562.86969.9f. Erratum In: Anesth Analg. 2006 Mar;102(3):875.
- Ilfeld BM, Mariano ER, Williams BA, Woodard JN, Macario A. Hospitalization costs of total knee arthroplasty with a continuous femoral nerve block provided only in the hospital versus on an ambulatory basis: a retrospective, case-control, cost-minimization analysis. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):46-54. doi: 10.1016/j.rapm.2006.10.010.
- Sites BD, Chan VW, Neal JM, Weller R, Grau T, Koscielniak-Nielsen ZJ, Ivani G; American Society of Regional Anesthesia and Pain Medicine; European Society Of Regional Anaesthesia and Pain Therapy Joint Committee. The American Society of Regional Anesthesia and Pain Medicine and the European Society Of Regional Anaesthesia and Pain Therapy Joint Committee recommendations for education and training in ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):40-6. doi: 10.1097/AAP.0b013e3181926779.
- Hadzic A, Vloka JD, Kuroda MM, Koorn R, Birnbach DJ. The practice of peripheral nerve blocks in the United States: a national survey [p2e comments]. Reg Anesth Pain Med. 1998 May-Jun;23(3):241-6.
- Kopacz DJ, Neal JM. Regional anesthesia and pain medicine: residency training--the year 2000. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):9-14. doi: 10.1053/rapm.2002.29715.
- Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia
- Marhofer P, Chan VW. Ultrasound-guided regional anesthesia: current concepts and future trends. Anesth Analg. 2007 May;104(5):1265-9, tables of contents. doi: 10.1213/01.ane.0000260614.32794.7b.
- Mariano ER, Cheng GS, Choy LP, Loland VJ, Bellars RH, Sandhu NS, Bishop ML, Lee DK, Maldonado RC, Ilfeld BM. Electrical stimulation versus ultrasound guidance for popliteal-sciatic perineural catheter insertion: a randomized controlled trial. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):480-5. doi: 10.1097/AAP.0b013e3181ada57a.
- Mariano ER, Loland VJ, Sandhu NS, Bellars RH, Bishop ML, Afra R, Ball ST, Meyer RS, Maldonado RC, Ilfeld BM. Ultrasound guidance versus electrical stimulation for femoral perineural catheter insertion. J Ultrasound Med. 2009 Nov;28(11):1453-60. doi: 10.7863/jum.2009.28.11.1453.
- Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.
- Boulet JR, Murray DJ. Simulation-based assessment in anesthesiology: requirements for practical implementation. Anesthesiology. 2010 Apr;112(4):1041-52. doi: 10.1097/ALN.0b013e3181cea265.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24882
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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