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Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES) (TRACES)

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ClinicalTrials.gov Identifier: NCT04862611
Recruitment Status : Completed
First Posted : April 28, 2021
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Anthony Chau, University of British Columbia

Study Description
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Brief 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. 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.

Condition or disease
Neuraxial Anesthesia Charting

Study Design
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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)
Actual Study Start Date : January 5, 2021
Actual Primary Completion Date : May 5, 2021
Actual Study Completion Date : May 5, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percent accuracy of recorded neuraxial attempts [ Time Frame: 1 day post-operatively ]
    Charted neuraxial attempts divided by observed neuraxial attempts


Secondary Outcome Measures :
  1. Percent accuracy of recorded neuraxial redirections [ Time Frame: 1 day post-operatively ]
    Charted neuraxial attempts divided by number of observed attempts and redirections

  2. Define a neuraxial attempt [ Time Frame: 1 month before recruitment starts ]
    Use thorough literature review to establish a working definition of a neuraxial attempt

  3. Define a neuraxial redirection [ Time Frame: 1 month before observations start ]
    Use thorough literature review to establish a working definition of a neuraxial redirection

  4. Departmental consensus on a neuraxial attempt [ Time Frame: One week after observations conclude ]
    Survey the department to understand how staff define a neuraxial attempt

  5. Completeness of documentation [ Time Frame: 1 day post-operatively ]
    Percentage completion of requisite charting prompts on anesthesia record


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients must meet the inclusion criteria, and give verbal consent to being watched. Providers must give verbal consent to being watched
Criteria

Inclusion Criteria:

  • Healthy parturients receiving any neuraxial procedure

Exclusion Criteria:

  • Patient refusal of observation
  • Provider refusal of observation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862611


Locations
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Canada, British Columbia
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Anthony Chau, MD University of British Columbia
More Information
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Responsible Party: Anthony Chau, Clinical assistant professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04862611    
Other Study ID Numbers: TRACES
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Chau, University of British Columbia:
neuraxial attempts
anesthetic charting
anesthetic documentation