Spinal Anesthesia SkillMAP-RachisNCT06533488
Evaluation of a Perceptual Learning Module on Spinal Ultrasound Among Residents.
A study testing Perceptual learning module in people with Spinal Anesthesia Skill and Ultrasound Imaging of Anatomical Structures, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
This medical education research project aims to evaluate the impact of a directed perceptual learning module (PLM) on spinal sonoanatomy. Following a demographic questionnaire, participants will be exposed to a tutorial explaining the necessary theoretical foundations for the PLM as well as the functioning of the PLM… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia Skill, Ultrasound Imaging of Anatomical Structures, Medical Education
- What is being tested?
- Perceptual learning module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2024to Apr 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be a first, second, third, or fourth-year resident in the anesthesiology program at the Université de Montréal.
- Not having experience in spinal ultrasound (defined as not having performed more than 5 spinal ultrasounds, whether accompanied or not).
- To be familiar with ultrasound.
- Consenting to participate in the study.
- Having used spinal ultrasound in clinical practice or taught it within the last year.
Who cannot join
- Refusal to consent
- Not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Issam Tanoubi, MD, 514-252-3400, i.tanoubi@umontreal.ca
Tanoubi
About this study
Official title: Evaluation of the Impact of a Perceptual Learning Module (PLM) on the Sonographic Identification of Spinal Structures by Novice Anesthesiology Residents. A Randomized Controlled Study
This medical education research project aims to evaluate the impact of a directed perceptual learning module (PLM) on spinal sonoanatomy. Following a demographic questionnaire, participants will be exposed to a tutorial explaining the necessary theoretical foundations for the PLM as well as the functioning of the PLM interface. A pre-test involving selecting the best image from a video sequence depicting spinal sonoanatomy will be administered to all participants. Participants will then be randomized into two groups and exposed to video sequences in the same manner as during the pre-test, with immediate feedback in the intervention group and no feedback in the control group. The video sequences presented will be the same between the two groups. Finally, a post-test will be administered immediately and remotely after exposure to the PLM. The time window corresponding to the best image will be predefined by an expert and compared to the resident\'s value. The difference in feedback exposure between the two groups will not be revealed to limit biases.
- Being tested
- Perceptual learning module, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual learning moduleOther
Perceptual learning module providing feedback on the most relevant image for clinical practice in a spinal ultrasound video.
ControlOther
Participants in the control group will view the same videos as participants in the intervention group without feedback on the best image.
| Study group | Role | What they receive |
|---|---|---|
| Feedback group | Experimental | This group will receive feedback upon completion of the task. Receives: Other: Perceptual learning module |
| Control group | Placebo comparator | This group will not receive any feedback Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the concordance of identifying the best image on the video within the interval specified by the expert in seconds, between the pre-test and the post-test.
Measured: Between the pre-test and the immediate post-test, as well as the post-test at 1 month.
Secondary outcomes (1)
Improvement over time in the concordance of identifying the best image on the video within the interval specified by the expert in seconds
Measured: During the intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start26 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia SkillStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issam TANOUBI, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533488
- Sponsor's protocol ID
- 2024-3447
- Acronym
- MAP-Rachis
- Status last verified
- Jul 2024
- First submitted
- 2 Apr 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guegan S, Steichen O, Soria A. Literature review of perceptual learning modules in medical education: What can we conclude regarding dermatology? Ann Dermatol Venereol. 2021 Mar;148(1):16-22. doi: 10.1016/j.annder.2020.01.023. Epub 2020 Jul 9.
PubMed 32654795Kellman PJ, Krasne S. Accelerating expertise: Perceptual and adaptive learning technology in medical learning. Med Teach. 2018 Aug;40(8):797-802. doi: 10.1080/0142159X.2018.1484897. Epub 2018 Aug 9.
PubMed 30091650VanderWielen BA, Harris R, Galgon RE, VanderWielen LM, Schroeder KM. Teaching sonoanatomy to anesthesia faculty and residents: utility of hands-on gel phantom and instructional video training models. J Clin Anesth. 2015 May;27(3):188-94. doi: 10.1016/j.jclinane.2014.07.007. Epub 2014 Nov 27.
PubMed 25433727Deacon AJ, Melhuishi NS, Terblanche NC. CUSUM method for construction of trainee spinal ultrasound learning curves following standardised teaching. Anaesth Intensive Care. 2014 Jul;42(4):480-6. doi: 10.1177/0310057X1404200409.
PubMed 24967763Watson MJ, Evans S, Thorp JM. Could ultrasonography be used by an anaesthetist to identify a specified lumbar interspace before spinal anaesthesia? Br J Anaesth. 2003 Apr;90(4):509-11. doi: 10.1093/bja/aeg096.
PubMed 12644427Ramlogan R, Niazi AU, Jin R, Johnson J, Chan VW, Perlas A. A Virtual Reality Simulation Model of Spinal Ultrasound: Role in Teaching Spinal Sonoanatomy. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):217-222. doi: 10.1097/AAP.0000000000000537.
PubMed 28045758Chin KJ, Perlas A. Ultrasonography of the lumbar spine for neuraxial and lumbar plexus blocks. Curr Opin Anaesthesiol. 2011 Oct;24(5):567-72. doi: 10.1097/ACO.0b013e32834aa234.
PubMed 21822134Margarido CB, Arzola C, Balki M, Carvalho JC. Anesthesiologists' learning curves for ultrasound assessment of the lumbar spine. Can J Anaesth. 2010 Feb;57(2):120-6. doi: 10.1007/s12630-009-9219-2. Epub 2009 Dec 30.
PubMed 20041358Sidiropoulou T, Christodoulaki K, Siristatidis C. Pre-Procedural Lumbar Neuraxial Ultrasound-A Systematic Review of Randomized Controlled Trials and Meta-Analysis. Healthcare (Basel). 2021 Apr 17;9(4):479. doi: 10.3390/healthcare9040479.
PubMed 33920621
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Perceptual Learning Module (PLM) on the Sonographic Identification of Spinal Structures by Novice Anesthesiology Residents. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06533488
- Acronym / sponsor ID
- MAP-Rachis / 2024-3447
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
This medical education research project aims to evaluate the impact of a directed perceptual learning module (PLM) on spinal sonoanatomy. Following a demographic questionnaire, participants will be exposed to a tutorial explaining the necessary theoretical foundations for the PLM as well as the functioning of the PLM interface. A pre-test involving selecting the best image from a video sequence depicting spinal sonoanatomy will be administered to all participants. Participants will then be randomized into two groups and exposed to video sequences in the same manner as during the pre-test, with immediate feedback in the intervention group and no feedback in the control group. The video sequences presented will be the same between the two groups. Finally, a post-test will be administered immediately and remotely after exposure to the PLM. The time window corresponding to the best image will be predefined by an expert and compared to the resident\'s value. The difference in feedback exposure between the two groups will not be revealed to limit biases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback group | Experimental | Other: Perceptual learning moduleThis group will receive feedback upon completion of the task. |
| Control group | Placebo comparator | Other: ControlThis group will not receive any feedback |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- To be a first, second, third, or fourth-year resident in the anesthesiology program at the Université de Montréal.
- Not having experience in spinal ultrasound (defined as not having performed more than 5 spinal ultrasounds, whether accompanied or not).
- To be familiar with ultrasound.
- Consenting to participate in the study.
- Having used spinal ultrasound in clinical practice or taught it within the last year.
Key exclusion criteria (2 listed)
- Refusal to consent
- Not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceptual learning modulePerceptual learning module providing feedback on the most relevant image for clinical practice in a spinal ultrasound video. | Other | Feedback group |
| ControlParticipants in the control group will view the same videos as participants in the intervention group without feedback on the best image. | Other | Control group |
Primary outcome
Improvement in the concordance of identifying the best image on the video within the interval specified by the expert in seconds, between the pre-test and the post-test.
Time frame: Between the pre-test and the immediate post-test, as well as the post-test at 1 month.
1 secondary outcome
Improvement over time in the concordance of identifying the best image on the video within the interval specified by the expert in seconds
Time frame: During the intervention phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Results publication: PubMed 32654795Guegan S, Steichen O, Soria A. Literature review of perceptual learning modules in medical education: What can we conclude regarding dermatology? Ann Dermatol Venereol. 2021 Mar;148(1):16-22. doi: 10.1016/j.annder.2020.01.023. Epub 2020 Jul 9.
- Results publication: PubMed 30091650Kellman PJ, Krasne S. Accelerating expertise: Perceptual and adaptive learning technology in medical learning. Med Teach. 2018 Aug;40(8):797-802. doi: 10.1080/0142159X.2018.1484897. Epub 2018 Aug 9.
- Results publication: PubMed 25433727VanderWielen BA, Harris R, Galgon RE, VanderWielen LM, Schroeder KM. Teaching sonoanatomy to anesthesia faculty and residents: utility of hands-on gel phantom and instructional video training models. J Clin Anesth. 2015 May;27(3):188-94. doi: 10.1016/j.jclinane.2014.07.007. Epub 2014 Nov 27.
- Results publication: PubMed 24967763Deacon AJ, Melhuishi NS, Terblanche NC. CUSUM method for construction of trainee spinal ultrasound learning curves following standardised teaching. Anaesth Intensive Care. 2014 Jul;42(4):480-6. doi: 10.1177/0310057X1404200409.
- Results publication: PubMed 12644427Watson MJ, Evans S, Thorp JM. Could ultrasonography be used by an anaesthetist to identify a specified lumbar interspace before spinal anaesthesia? Br J Anaesth. 2003 Apr;90(4):509-11. doi: 10.1093/bja/aeg096.
- Results publication: PubMed 28045758Ramlogan R, Niazi AU, Jin R, Johnson J, Chan VW, Perlas A. A Virtual Reality Simulation Model of Spinal Ultrasound: Role in Teaching Spinal Sonoanatomy. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):217-222. doi: 10.1097/AAP.0000000000000537.
- Results publication: PubMed 21822134Chin KJ, Perlas A. Ultrasonography of the lumbar spine for neuraxial and lumbar plexus blocks. Curr Opin Anaesthesiol. 2011 Oct;24(5):567-72. doi: 10.1097/ACO.0b013e32834aa234.
- Results publication: PubMed 20041358Margarido CB, Arzola C, Balki M, Carvalho JC. Anesthesiologists' learning curves for ultrasound assessment of the lumbar spine. Can J Anaesth. 2010 Feb;57(2):120-6. doi: 10.1007/s12630-009-9219-2. Epub 2009 Dec 30.
- Results publication: PubMed 33920621Sidiropoulou T, Christodoulaki K, Siristatidis C. Pre-Procedural Lumbar Neuraxial Ultrasound-A Systematic Review of Randomized Controlled Trials and Meta-Analysis. Healthcare (Basel). 2021 Apr 17;9(4):479. doi: 10.3390/healthcare9040479.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual learning module in people with Spinal Anesthesia Skill and Ultrasound Imaging of Anatomical Structures, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 5 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Issam Tanoubi, MD (514-252-3400, i.tanoubi@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the concordance of identifying the best image on the video within the interval specified by the expert in seconds, between the pre-test and the post-test. (time frame: Between the pre-test and the immediate post-test, as well as the post-test at 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533488, which also lists 9 linked publications.
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 1 Aug 2024.