Anesthesia EducationNCT04454801
Expert Behaviors USGRA
An observational study of Anesthesia Education, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia Education
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2020to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All elective patients coming to the regional BR at TWH aged 18-80
Who cannot join
- Any contraindication to USGRA (LA allergy, patient refusal, infection at injection site, etc.)
- Inability to read or speak or comprehend English fluently
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Anesthesia Education
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion
Reviewers will identify behaviors exhibited by the expert operators during pre-procedural discussion
Measured: 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
Measured: 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;
Measured: 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).
Measured: during procedure
Quantitative data on block effectiveness defined by blocks requiring top-up
number of top-up will be collected
Measured: 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
Measured: 0-1 hour after procedure
Quantitative data on time to surgical anesthesia
defined by final needle removal to surgical anesthesia
Measured: 0-1 hour after procedure
Quantitative data on time to block completion
defined by needle insertion to final needle removal
Measured: 0-1 hour after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start15 Aug 2020 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia EducationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Jinn Chin, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454801
- Sponsor's protocol ID
- 19-6238
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Behaviors in Ultrasound Guided Regional Anesthesia A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT04454801
- Acronym / sponsor ID
- 19-6238
- Conditions
- Anesthesia Education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Aug 2020 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All elective patients coming to the regional BR at TWH aged 18-80
Key exclusion criteria (2 listed)
- Any contraindication to USGRA (LA allergy, patient refusal, infection at injection site, etc.)
- Inability to read or speak or comprehend English fluently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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;
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).
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
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
Quantitative data on time to surgical anesthesia
Time frame: 0-1 hour after procedure
defined by final needle removal to surgical anesthesia
Quantitative data on time to block completion
Time frame: 0-1 hour after procedure
defined by needle insertion to final needle removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Jinn Chin, MD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Education, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongyu (Cindy) Jin (416-603-5800 ext. 2016, rongyu.jin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion (time frame: 1 hour before procedure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.