Utilizing Ultrasound for Residents as an Aid in Epidural Placement

NCT ID: NCT03378492

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2020-11-30

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.

Conditions

Epidural Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Standard Epidural

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

Group Type: ACTIVE_COMPARATOR

Standard Epidural

Intervention Type: 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.

Ultrasound Guided Epidural

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

Group Type: EXPERIMENTAL

Ultrasound Guided Epidural

Intervention Type: 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.

Interventions

Ultrasound Guided Epidural

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.

Intervention Type: DEVICE

Standard Epidural

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2000021722

Identifier Type: -

Identifier Source: org_study_id