Utilizing Ultrasound for Residents as an Aid in Epidural Placement

Yale University0 sitesAugust 2018

ConditionsEpidural Placement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epidural Placement
Sponsor: Yale University
Primary Endpoint: Success Rate
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.

Detailed Description

The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.

Registry

clinicaltrials.gov

Start Date

August 2018

End Date

November 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Yale University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients presenting for vaginal delivery
•ASA-1, ASA-2, and ASA-3
•Patients with no known back deformities
•Ability to sit upright for epidural placement
•No prior lumbar surgery
•No allergies to ultrasound gel
•Pre-pregnancy BMI \>= 30

Exclusion Criteria

•Patients \< 18 years of age

Outcomes

Primary Outcomes

Success Rate

Time Frame: Baseline (at time of procedure)

Success rates are defined as successful epidural administration on the first needle insertion attempt. This outcome will be a dichotomous (yes/no) outcome.

Secondary Outcomes

Time to landmark identification(Baseline (at time of procedure))
Total technical procedure time(Baseline (at time of procedure))
Pain(Baseline (at time of procedure))
Analgesia efficacy rate(Baseline (at time of procedure))
Needle passes(Baseline (at time of procedure))
Needle insertion attempts(Baseline (at time of procedure))
Accuracy of needle insertion(Baseline (at time of procedure))
Vertebral level of epidural placement(Baseline (at time of procedure))
Epidural space depth(Baseline (at time of procedure))
Time to loss of resistance(Baseline (at time of procedure))
Time to complete epidural analgesia administration(Baseline (at time of procedure))
Time to comfort(Baseline (at time of procedure))
Patient satisfaction(Follow Up (Up to 1 day))