Neuraxial Anesthesia ChartingTRACESNCT04862611
Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)
An observational study of Neuraxial Anesthesia Charting, run by University of British Columbia at 1 site in Canada.
Trial summary
The goal of this study is to compare observed neuraxial (Epidural, spinal, combined spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers (staff, residents and fellows) at one maternal hospital. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuraxial Anesthesia Charting
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2021to 5 May 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 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients must meet the inclusion criteria, and give verbal consent to being watched. Providers must give verbal consent to being watched
Who may be able to join
- Healthy parturients receiving any neuraxial procedure
Who cannot join
- Patient refusal of observation
- Provider refusal of observation
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to compare observed neuraxial (Epidural, spinal, combined spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers (staff, residents and fellows) at one maternal hospital. Trained research staff will document the number of neuraxial attempts before the operation, and compare this with the attempts recorded in the patient's chart. The definition of a neuraxial attempt will be determined before the study begins through a thorough literature review.
- Conditions
- Neuraxial Anesthesia Charting
- Keywords
- neuraxial attempts, anesthetic charting, anesthetic documentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent accuracy of recorded neuraxial attempts
Charted neuraxial attempts divided by observed neuraxial attempts
Measured: 1 day post-operatively
Secondary outcomes (5)
Percent accuracy of recorded neuraxial redirections
Charted neuraxial attempts divided by number of observed attempts and redirections
Measured: 1 day post-operatively
Define a neuraxial attempt
Use thorough literature review to establish a working definition of a neuraxial attempt
Measured: 1 month before recruitment starts
Define a neuraxial redirection
Use thorough literature review to establish a working definition of a neuraxial redirection
Measured: 1 month before observations start
Departmental consensus on a neuraxial attempt
Survey the department to understand how staff define a neuraxial attempt
Measured: One week after observations conclude
Completeness of documentation
Percentage completion of requisite charting prompts on anesthesia record
Measured: 1 day post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start5 Jan 2021
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuraxial Anesthesia ChartingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anthony Chau, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862611
- Sponsor's protocol ID
- TRACES
- Acronym
- TRACES
- Status last verified
- Sep 2021
- First submitted
- 22 Apr 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)
- ClinicalTrials.gov ID
- NCT04862611
- Acronym / sponsor ID
- TRACES / TRACES
- Conditions
- Neuraxial Anesthesia Charting
- Keywords
- neuraxial attempts, anesthetic charting, anesthetic documentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 28 Apr 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 study is to compare observed neuraxial (Epidural, spinal, combined spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers (staff, residents and fellows) at one maternal hospital. Trained research staff will document the number of neuraxial attempts before the operation, and compare this with the attempts recorded in the patient's chart. The definition of a neuraxial attempt will be determined before the study begins through a thorough literature review.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must meet the inclusion criteria, and give verbal consent to being watched. Providers must give verbal consent to being watched
Key inclusion criteria (1 listed)
- Healthy parturients receiving any neuraxial procedure
Key exclusion criteria (2 listed)
- Patient refusal of observation
- Provider refusal of observation
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
Percent accuracy of recorded neuraxial attempts
Time frame: 1 day post-operatively
Charted neuraxial attempts divided by observed neuraxial attempts
5 secondary outcomes
Percent accuracy of recorded neuraxial redirections
Time frame: 1 day post-operatively
Define a neuraxial attempt
Time frame: 1 month before recruitment starts
Define a neuraxial redirection
Time frame: 1 month before observations start
Departmental consensus on a neuraxial attempt
Time frame: One week after observations conclude
Completeness of documentation
Time frame: 1 day post-operatively
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 1 Oct 2021.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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.
Anthony Chau, MD principal investigator
University of British Columbia
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 Neuraxial Anesthesia Charting, run by University of British Columbia 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 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: finished, as of the sponsor's last update on 1 Oct 2021. 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. 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?
Percent accuracy of recorded neuraxial attempts (time frame: 1 day post-operatively). 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 1 Oct 2021.