<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688271</url>
  </required_header>
  <id_info>
    <org_study_id>24882</org_study_id>
    <nct_id>NCT01688271</nct_id>
  </id_info>
  <brief_title>Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion</brief_title>
  <official_title>A Prospective Study to Determine the Efficacy of Simulation-based Training on Practicing Anesthesiologists' Acquisition of Ultrasound-guided Perineural Catheter Insertion Skills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Palo Alto Health Care System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the efficacy of a teaching program incorporating hybrid simulation&#xD;
      in training practicing anesthesiologists on ultrasound (US)-guided continuous peripheral&#xD;
      nerve block (CPNB).&#xD;
&#xD;
      This study will also examine the extent of practice change following participation in a&#xD;
      regional anesthesia teaching program incorporating hybrid simulation. In addition, this study&#xD;
      will assess remaining obstacles to incorporating the use of US-guided perineural catheters&#xD;
      through identifying potential future interventions and &quot;tool-kits&quot; for setting up perineural&#xD;
      catheter programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study subjects will complete a pre-course survey to assess prior experience then participate&#xD;
      in a standardized one-day workshop comprised of two sessions; 1) a didactic lecture and model&#xD;
      scanning session and 2) a simulation session. Quantitative and qualitative assessments will&#xD;
      be performed using video analysis by two blinded reviewers after equipment orientation&#xD;
      (baseline), following first session, and following second session. Performance times, number&#xD;
      of attempts, and composite scores for procedural performance and ergonomics will be analyzed&#xD;
      within and between groups. Every 3 months for one year, subjects will be surveyed to assess&#xD;
      implementation of PNB in practice and identify remaining barriers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in video assessment score from baseline</measure>
    <time_frame>baseline (time 0), interval assessment (time 1), and post-course (time 2)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implementation of new training</measure>
    <time_frame>Every 3 months post-training for 1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Pain Management</condition>
  <condition>Simulation</condition>
  <condition>Training</condition>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>Anesthesiologists</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Active board certificated (American Board of Anesthesiologists) Anesthesiologists in&#xD;
        practice ten years or more.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anesthesiologists in practice ten years or more; active board certification (American&#xD;
             Board of Anesthesiologists); active license to practice medicine in California; and&#xD;
             willingness to spend one full day (8 hours) participating in the standardized workshop&#xD;
             and undergo interval survey and interview follow-up for one year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Formal training (e.g., post-graduate fellowship) in regional anesthesia; current&#xD;
             practice includes the routine performance of US-guided PNB (≥10 blocks per month); or&#xD;
             visual, hearing, or other communication impairment that would interfere with video&#xD;
             recording or require substantial deviation from the standardized teaching curriculum.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward R Mariano, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Palo Alto Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>17350520</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21296245</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15920221</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16368810</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17196492</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19258987</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9613533</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11799499</PMID>
  </reference>
  <reference>
    <citation>Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17456684</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19920423</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19854959</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22157743</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20234313</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>October 27, 2014</last_update_submitted>
  <last_update_submitted_qc>October 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Palo Alto Health Care System</investigator_affiliation>
    <investigator_full_name>Edward R. Mariano</investigator_full_name>
    <investigator_title>Chief, Anesthesiology and Perioperative Care and Associate Professor of Anesthesia Stanford University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>simulation</keyword>
  <keyword>ultrasound</keyword>
  <keyword>perineural infusion</keyword>
  <keyword>continuous peripheral nerve block</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688271
org study id: 24882
nct id: NCT01688271
lead sponsor: 
collaborator: 
has dmc: Yes
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 subjects will complete a pre-course survey to assess prior experience then participate
      in a standardized one-day workshop comprised of two sessions; 1) a didactic lecture and model
      scanning session and 2) a simulation session. Quantitative and qualitative assessments will
      be performed using video analysis by two blinded reviewers after equipment orientation
      (baseline), following first session, and following second session. Performance times, number
      of attempts, and composite scores for procedural performance and ergonomics will be analyzed
      within and between groups. Every 3 months for one year, subjects will be surveyed to assess
      implementation of PNB in practice and identify remaining barriers.
observational model: Case-Only
time perspective: Prospective
measure: Change in video assessment score from baseline
time frame: baseline (time 0), interval assessment (time 1), and post-course (time 2)
description: 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.
measure: Implementation of new training
time frame: Every 3 months post-training for 1 year
description: 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.
arm group label: Anesthesiologists
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edward R Mariano, MD, MAS
role: Principal Investigator
affiliation: VA Palo Alto Health Care System
facility: 
country: United States
citation: 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.
PMID: 17350520
citation: 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.
PMID: 21296245
citation: 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.
PMID: 15920221
citation: 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.
PMID: 16368810
citation: 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.
PMID: 17196492
citation: 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.
PMID: 19258987
citation: 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.
PMID: 9613533
citation: 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.
PMID: 11799499
citation: Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia
citation: 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.
PMID: 17456684
citation: 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.
PMID: 19920423
citation: 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.
PMID: 19854959
citation: 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.
PMID: 22157743
citation: 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.
PMID: 20234313
responsible party type: Principal Investigator
investigator affiliation: VA Palo Alto Health Care System
investigator full name: Edward R. Mariano
investigator title: Chief, Anesthesiology and Perioperative Care and Associate Professor of Anesthesia Stanford University School of Medicine