Utilizing Ultrasound for Residents as an Aid in Epidural Placement

January 8, 2019 updated by: Yale University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Epidural
Participants in this group will have epidurals placed using standard practice.
Procedure: 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.
Experimental: Ultrasound Guided Epidural
Participants in this group will have epidurals placed using standard practice with the assistance of ultrasound.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (at time of procedure)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Needle passes
Time Frame: Baseline (at time of procedure)
A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin. This outcome will capture the number of passes.
Baseline (at time of procedure)
Needle insertion attempts
Time Frame: Baseline (at time of procedure)
The number of needle insertion attempts is defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt.
Baseline (at time of procedure)
Accuracy of needle insertion
Time Frame: Baseline (at time of procedure)
The accuracy of needle insertion location is determined by the need to redirect (different angle) or reinsert the needle (different skin puncture site). This outcome will describe qualitatively the accuracy of the needle placement.
Baseline (at time of procedure)
Vertebral level of epidural placement
Time Frame: Baseline (at time of procedure)
Vertebral level of epidural placement is a record of the vertebral level where the epidural is administered. This will be confirmed via ultrasound imaging in both standard group and ultrasound group following epidural administration.
Baseline (at time of procedure)
Time to landmark identification
Time Frame: Baseline (at time of procedure)
Time to landmark identification is defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the standard group and ultrasound group corresponds to when the resident physician first places his/her hand on the patient to palpate the back.
Baseline (at time of procedure)
Time to loss of resistance
Time Frame: Baseline (at time of procedure)
Time to loss of resistance is defined as the time interval between the first needle puncture attempt and the observation of loss of resistance.
Baseline (at time of procedure)
Time to complete epidural analgesia administration
Time Frame: Baseline (at time of procedure)
Time to complete epidural analgesia administration is defined as the time interval between the observation of loss of resistance and administration of analgesics through the epidural catheter.
Baseline (at time of procedure)
Total technical procedure time
Time Frame: Baseline (at time of procedure)
Total technical procedure time is defined as the sum of (iv) Time to landmark identification, (v) Time to loss of resistance, and (vi) Time to complete epidural analgesia administration. This technical procedure time measure the time between first placing hands on the patient to the administration of analgesia.
Baseline (at time of procedure)
Epidural space depth
Time Frame: Baseline (at time of procedure)
Epidural space depth is the depth from the skin to the epidural space as measured in centimeters (accurate to 0.1 cm).
Baseline (at time of procedure)
Pain
Time Frame: Baseline (at time of procedure)
Pain during epidural administration: to be assessed after the completion of catheter insertion (verbal rating scale [VRS], 0-10, 0 = no pain, 10 = maximum pain).
Baseline (at time of procedure)
Analgesia efficacy rate
Time Frame: Baseline (at time of procedure)
Analgesia efficacy rate: defined as VRS <= 1 and absence of unilateral or failed block at 20 minutes after injection of the loading dose
Baseline (at time of procedure)
Time to comfort
Time Frame: Baseline (at time of procedure)
Time to comfort after administration of the loading dose will be recorded in minutes.
Baseline (at time of procedure)
Patient satisfaction
Time Frame: Follow Up (Up to 1 day)
Patient satisfaction with the epidural administration, assessed after the administration of the loading dose (scale 0-10, 0 = not satisfied, 10 = completely satisfied).
Follow Up (Up to 1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000021722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epidural Placement

Clinical Trials on Standard Epidural

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings