The Impact of Needle Manipulation and Accuracy Between Hand Held Automatic and Traditional Ultrasound Device

September 10, 2025 updated by: Yale University

A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices

In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study).

Number of needle insertion attempts: 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. Time to landmark identification: 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 LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Coagulopathy
  • Low platelet count
  • Allergies to local anesthetics

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Handheld traditional ultrasound
Traditional US will be used to compare number of needle manipulations to the handheld US.
Device: Traditional ultrasound
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
Other: Handheld Automated ultrasound
Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.
Device: Automated ultrasound
Labor epidural will be performed after marking patient skin using an automated ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of needle passes
Time Frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Number of ventral needle movements without removing needle from skin. A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin.
From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Needle attempts
Time Frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Number of times the needle is advanced in and out of the skin
From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Time to obtain ultrasound images with traditional ultrasound device
Time Frame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time from placing ultrasound on patients back until markings are complete
Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time to obtain images with automated ultrasound device
Time Frame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time from placing ultrasound on patients back until markings are complete
Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time from local anesthetic injection till time of epidural space identification
Time Frame: Up to 60 minutes
Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance
Up to 60 minutes
Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance
Time Frame: Up to 60 minutes
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Up to 60 minutes
Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance
Time Frame: Up to 60 minutes
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Up to 60 minutes
Patient satisfaction
Time Frame: 15 - 20 minutes after epidural placement
Assessed after the administration of the loading dose. Patient will be asked to rate their pain on a scale 0-10, 0 = not satisfied, 10 = completely satisfied
15 - 20 minutes after epidural placement

Collaborators and Investigators

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

Sponsor

Yale University

Investigators

  • Principal Investigator: Antonio Gonzalez, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2000034863
  • No NIH funding 09.05.23 (Other Identifier: Yale)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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.

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