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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05909085
Status
Not Yet Recruiting

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Conditions

  • Labor Analgesia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Handheld traditional ultrasound
    Traditional US will be used to compare number of needle manipulations to the handheld US.
  • Other: Handheld Automated ultrasound
    Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.

Primary Outcome Measure

Number of needle passes [ Time Frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510-

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By research site
Yale University· New Haven, CT

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