Tracking Attempts of CSE, Epidural and Spinal Insertions... | NCT04862611

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

NCT04862611

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Oct 1, 2021Actual

Enrollment

220Actual

Phase

Not provided

Conditions

Neuraxial Anesthesia Charting

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2021Actual

Primary Completion Date

May 5, 2021Actual

Completion Date

May 5, 2021Actual

First Submitted Date

Apr 22, 2021

First Submission Date that Met QC Criteria

Apr 26, 2021

First Posted Date

Apr 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2021

Last Update Posted Date

Oct 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony Chau, Clinical assistant professor, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy parturients receiving any neuraxial procedure

Exclusion Criteria:

Patient refusal of observation
Provider refusal of observation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients must meet the inclusion criteria, and give verbal consent to being watched. Providers must give verbal consent to being watched

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Chau, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Women's Hospital		Vancouver	British Columbia	V6H 3N1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided