NCT04454801

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

July 31, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 30, 2020

Last Update Submit

July 29, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion

    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

    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;

    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)

    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

    number of top-up will be collected

    0-1 hour after procedure

  • Quantitative data on block effectiveness defined by blocks requiring conversion to GA

    Incidence will be documented in case conversion to GA is needed

    0-1 hour after procedure

  • Quantitative data on time to surgical anesthesia

    defined by final needle removal to surgical anesthesia

    0-1 hour after procedure

  • Quantitative data on time to block completion

    defined by needle insertion to final needle removal

    0-1 hour after procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ki Jinn Chin, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu (Cindy) Jin

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 2, 2020

Study Start

August 15, 2020

Primary Completion

July 15, 2021

Study Completion

August 15, 2021

Last Updated

July 31, 2020

Record last verified: 2020-06