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

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 Overview

• Status: Completed
• Conditions: Neuraxial Anesthesia Charting

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

Inclusion Criteria:

• Healthy parturients receiving any neuraxial procedure

Exclusion Criteria:

• Patient refusal of observation
• Provider refusal of observation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent accuracy of recorded neuraxial attempts	Charted neuraxial attempts divided by observed neuraxial attempts	1 day post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent accuracy of recorded neuraxial redirections	Charted neuraxial attempts divided by number of observed attempts and redirections	1 day post-operatively
Define a neuraxial attempt	Use thorough literature review to establish a working definition of a neuraxial attempt	1 month before recruitment starts
Define a neuraxial redirection	Use thorough literature review to establish a working definition of a neuraxial redirection	1 month before observations start
Departmental consensus on a neuraxial attempt	Survey the department to understand how staff define a neuraxial attempt	One week after observations conclude
Completeness of documentation	Percentage completion of requisite charting prompts on anesthesia record	1 day post-operatively

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Anthony Chau, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): May 5, 2021
• Study Completion (Actual): May 5, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: neuraxial attempts; anesthetic charting; anesthetic documentation
• Other Study ID Numbers: TRACES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No