Utilizing Ultrasound for Residents as an Aid in Epidural Placement

NCT03378492 | Withdrawn FDA Device

• 1 other identifier: 2000021722
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epidural Placement

Outcome Measures

Primary Outcomes (1)

• Success Rate

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

  Baseline (at time of procedure)

Secondary Outcomes (13)

• 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)

• Time to landmark identification

  Baseline (at time of procedure)

Study Arms (2)

Standard Epidural

ACTIVE COMPARATOR

Participants in this group will have epidurals placed using standard practice.

Procedure: Standard Epidural

Ultrasound Guided Epidural

EXPERIMENTAL

Participants in this group will have epidurals placed using standard practice with the assistance of ultrasound.

Device: Ultrasound Guided Epidural

Interventions

Ultrasound Guided Epidural DEVICE

Sterile ultrasound gel will be applied to the patient's back and the sterile device will be used to image the lumbar vertebrae in the area of the palpation-derived location. When the device is placed above the vertebral interspace, the 3D image mode will identify the spine midline and the depth from the skin to the epidural space. A single 3D ultrasound video loop of the vertebral interspace will be saved to confirm correct landmark identification. After identification of the vertebral interspace, the skin will be marked with a marking utensil or physical indentation at the point of needle entry indicated by the device. The epidural needle will then be placed in the same fashion as in the standard procedure group. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance.

Ultrasound Guided Epidural

Standard Epidural PROCEDURE

The point of needle entry will be located using the landmarks technique. The specific level of epidural placement will be determined on a per-patient basis at the anesthesiologist's discretion. The spine midline will also be palpated to determine the approximate location of an interlaminar space. The needle will then be inserted at the appropriate location determined by the landmarks technique, and successful epidural placement will be confirmed by observation of loss of resistance and follow-up confirmation of analgesia. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. The epidural catheter will be inserted and the procedure will continue according to the standard of care.

Standard Epidural

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients \< 18 years of age

Sponsors & Collaborators

• Yale University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 19, 2017
• Study Start: August 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: January 10, 2019

Record last verified: 2019-01