Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05909085

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional ultrasound

Device

Labor epidural will be performed after marking patient skin using traditional ultrasound guidance

Automated ultrasound

Device

Labor epidural will be performed after marking patient skin using an automated ultrasound device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Gonzalez, MD

CONTACT

[email protected]

4133869415

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.