Expert Behaviors USGRA

July 29, 2020 updated by: University Health Network, Toronto

Expert Behaviors in Ultrasound Guided Regional Anesthesia A Mixed-Methods Study

Expert-performance begins by focusing specifically on the end-product of training and experience in the hands of the expert. By defining expert behaviors and techniques, investigators can guide learners and non-expert practitioners by offering them models to emulate. At Toronto Western Hospital (TWH), there are more than ten expert attending regional anesthesiologists who routinely provide clinical patient care in the block room. The primary objective of this study is to qualitatively and quantitatively examine behavior of experts performing ultrasound guided regional anesthesia techniques to identify those which are consistent and unique, and which may underpin expert performance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This is a mixed methods assessment study to be completed at TWH. We will recruit 10 fellowship-trained regional anesthesiology and pain medicine staff anesthesiologists to perform USGRA blocks while being video-recorded. Here, we specifically define expert as a staff anesthesiologist who has completed a fellowship in regional anesthesia and/or chronic pain and has at least 6-years of post-fellowship clinical experience with USGRA.

Consent will also be sought from 180 patients undergoing USGRA for surgical procedures at TWH to have the block completed by an expert, as previously defined, and to have the procedure recorded.

Description

Inclusion Criteria:

  • All elective patients coming to the regional BR at TWH aged 18-80

Exclusion Criteria:

  • Any contraindication to USGRA (LA allergy, patient refusal, infection at injection site, etc.)
  • Inability to read or speak or comprehend English fluently

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion
Time Frame: 1 hour before procedure
Reviewers will identify behaviors exhibited by the expert operators during pre-procedural discussion
1 hour before procedure
Qualitative behaviors of experts performing UGRA techniques during patient and equipment preparation
Time Frame: 0.5 hour before procedure
Reviewers will identify behaviors exhibited by the expert operators during patient and equipment preparation
0.5 hour before procedure
Qualitative behaviours of experts performing UGRA techniques during ultrasound scanning of the target area;
Time Frame: 10 minutes before procedure
Reviewers will identify behaviors exhibited by the expert operators during ultrasound scanning of the target area;
10 minutes before procedure
Qualitative behaviours of experts performing UGRA techniques during needle advancement and local anesthetic deposition around the target nerve(s)
Time Frame: during procedure
Reviewers will identify behaviors exhibited by the expert operators during needle advancement and local anesthetic deposition around the target nerve(s).
during procedure
Quantitative data on block effectiveness defined by blocks requiring top-up
Time Frame: 0-1 hour after procedure
number of top-up will be collected
0-1 hour after procedure
Quantitative data on block effectiveness defined by blocks requiring conversion to GA
Time Frame: 0-1 hour after procedure
Incidence will be documented in case conversion to GA is needed
0-1 hour after procedure
Quantitative data on time to surgical anesthesia
Time Frame: 0-1 hour after procedure
defined by final needle removal to surgical anesthesia
0-1 hour after procedure
Quantitative data on time to block completion
Time Frame: 0-1 hour after procedure
defined by needle insertion to final needle removal
0-1 hour after procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ki Jinn Chin, MD, University Health Network, Toronto

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-6238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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