Anesthesia, LocalNCT05153265
The CIA Score: a Learner's Tool
An observational study of Anesthesia, Local, run by Stanford University at 1 site in United States.
Trial summary
The goal of this project is to use a previously described scoring system - the CIA system - as a teaching tool to help learners assess the bleeding risk of peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Survey
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2021to 23 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stanford Regional Anesthesia attending physicians and residents
Who may be able to join
- Regional Anesthesiologist and interested staff from Stanford
Who cannot join
- Non-regional anesthesiologists and non-interested staff at Stanford
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Critical, Intervention, Assess: Using the CIA System as a Learning Tool to Assess Bleeding Risk in Regional Anesthesia.
The goal of this project is to use a previously described scoring system - the CIA system - as a teaching tool to help learners assess the bleeding risk of peripheral nerve blocks. We will teach the CIA system to residents, then they will complete a survey in which they apply the system to various peripheral nerve blocks. We hypothesize that the CIA system will allow learners to reach the same consensus about bleeding risk as expert opinions.
Read the detailed description
Prior survey of Stanford and Palo Alto VA regional anesthesiologists showed diverging assessments of whether various blocks are considered superficial or deep. Investigators hope to have a simple systematic approach to "scoring" regional anesthesia procedures which can be used as a basis for discussion and comparison of regional expert's opinions.
A scoring system using three categories of consideration to classify any regional procedure is proposed. The following three categories, Critical, Intervention, and Assess (CIA) can be used to analyze any procedure to determine bleeding risk. A score of 0 or 1, was given to each parameter depending on whether it was absent or present. A total score can be range from 0 to 3. From this, the risk can be categorized based on the total score as low-risk (0), intermediate-risk (1) or high-risk (2 or 3).
- Conditions
- Anesthesia, Local
- Being tested
- Survey
- Keywords
- regional anesthesia, peripheral nerve block, acute pain medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
There will be no interventions for study participants. Participants will be asked to complete a survey.
| Study group | Role | What they receive |
|---|---|---|
| Residents | We plan to distribute a survey to the Stanford anesthesiology residents to determine their assessment of the bleeding risk of nerve blocks. The survey will list the most common nerve blocks and ask the resident anesthesiologists at Stanford whether the block is low/intermediate/high risk based on a scoring system of location relative to critical structures, compressibility, and whether bleeding or hematoma would be readily apparent. Receives: Other: Survey | |
| Attending physicians | We plan to distribute a survey to the Stanford anesthesiology attending physicians to determine their assessment of the bleeding risk of several different nerve blocks. The survey will list the most common nerve blocks and ask Stanford anesthesiologists whether the block is low/intermediate/high risk based on their experience with nerve blocks. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIA score by trainees
The bleeding risk of each peripheral nerve block as assessed by trainees, using the CIA scoring system.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start23 Nov 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153265
- Sponsor's protocol ID
- 48095
- Status last verified
- Mar 2022
- First submitted
- 29 Nov 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsui BCH, Kirkham K, Kwofie MK, Tran Q, Wong P, Chin KJ, Sondekoppam RV. Practice advisory on the bleeding risks for peripheral nerve and interfascial plane blockade: evidence review and expert consensus. Can J Anaesth. 2019 Nov;66(11):1356-1384. doi: 10.1007/s12630-019-01466-w. Epub 2019 Aug 26.
PubMed 31452012Tsui BCH. A systematic approach to scoring bleeding risk in regional anesthesia procedures. J Clin Anesth. 2018 Sep;49:69-70. doi: 10.1016/j.jclinane.2018.06.011. Epub 2018 Jun 15. No abstract available.
PubMed 29909204
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical, Intervention, Assess: Using the CIA System as a Learning Tool to Assess Bleeding Risk in Regional Anesthesia.
- ClinicalTrials.gov ID
- NCT05153265
- Acronym / sponsor ID
- 48095
- Conditions
- Anesthesia, Local
- Keywords
- regional anesthesia, peripheral nerve block, acute pain medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 10 Dec 2021 (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.
The goal of this project is to use a previously described scoring system - the CIA system - as a teaching tool to help learners assess the bleeding risk of peripheral nerve blocks. We will teach the CIA system to residents, then they will complete a survey in which they apply the system to various peripheral nerve blocks. We hypothesize that the CIA system will allow learners to reach the same consensus about bleeding risk as expert opinions.
Detailed description
Prior survey of Stanford and Palo Alto VA regional anesthesiologists showed diverging assessments of whether various blocks are considered superficial or deep. Investigators hope to have a simple systematic approach to "scoring" regional anesthesia procedures which can be used as a basis for discussion and comparison of regional expert's opinions.
A scoring system using three categories of consideration to classify any regional procedure is proposed. The following three categories, Critical, Intervention, and Assess (CIA) can be used to analyze any procedure to determine bleeding risk. A score of 0 or 1, was given to each parameter depending on whether it was absent or present. A total score can be range from 0 to 3. From this, the risk can be categorized based on the total score as low-risk (0), intermediate-risk (1) or high-risk (2 or 3).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents | – | Other: SurveyWe plan to distribute a survey to the Stanford anesthesiology residents to determine their assessment of the bleeding risk of nerve blocks. The survey will list the most common nerve blocks and ask the resident anesthesiologists at Stanford whether the block is low/intermediate/high risk based on a scoring system of location relative to critical structures, compressibility, and whether bleeding or hematoma would be readily apparent. |
| Attending physicians | – | Other: SurveyWe plan to distribute a survey to the Stanford anesthesiology attending physicians to determine their assessment of the bleeding risk of several different nerve blocks. The survey will list the most common nerve blocks and ask Stanford anesthesiologists whether the block is low/intermediate/high risk based on their experience with nerve blocks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stanford Regional Anesthesia attending physicians and residents
Key inclusion criteria (1 listed)
- Regional Anesthesiologist and interested staff from Stanford
Key exclusion criteria (1 listed)
- Non-regional anesthesiologists and non-interested staff at Stanford
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 |
|---|---|---|
| SurveyThere will be no interventions for study participants. Participants will be asked to complete a survey. | Other | Attending physicians, Residents |
Primary outcome
CIA score by trainees
Time frame: 2 months
The bleeding risk of each peripheral nerve block as assessed by trainees, using the CIA scoring system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Background: PubMed 31452012Tsui BCH, Kirkham K, Kwofie MK, Tran Q, Wong P, Chin KJ, Sondekoppam RV. Practice advisory on the bleeding risks for peripheral nerve and interfascial plane blockade: evidence review and expert consensus. Can J Anaesth. 2019 Nov;66(11):1356-1384. doi: 10.1007/s12630-019-01466-w. Epub 2019 Aug 26.
- Background: PubMed 29909204Tsui BCH. A systematic approach to scoring bleeding risk in regional anesthesia procedures. J Clin Anesth. 2018 Sep;49:69-70. doi: 10.1016/j.jclinane.2018.06.011. Epub 2018 Jun 15. No abstract available.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Stanford University at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 16 Mar 2022. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIA score by trainees (time frame: 2 months). 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 NCT05153265, which also lists 2 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 16 Mar 2022.