Simulation-Based Training for Ultrasound-Guided Perineural Catheter Insertion

October 27, 2014 updated by: Edward R. Mariano, VA Palo Alto Health Care System

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

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Active board certificated (American Board of Anesthesiologists) Anesthesiologists in practice ten years or more.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Anesthesiologists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in video assessment score from baseline
Time Frame: baseline (time 0), interval assessment (time 1), and post-course (time 2)
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.
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
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.
Every 3 months post-training for 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Edward R Mariano, MD, MAS, VA Palo Alto Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain Management

Subscribe