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

NCT05909085 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2000034863No NIH funding 09.05.23
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Analgesia

Outcome Measures

Primary Outcomes (1)

• Number of needle passes

  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 Outcomes (7)

• Number of Needle attempts

  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 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 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

  Up to 60 minutes

• Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance

  Up to 60 minutes

Study Arms (2)

Handheld traditional ultrasound

ACTIVE COMPARATOR

Traditional US will be used to compare number of needle manipulations to the handheld US.

Device: Traditional ultrasound

Handheld Automated ultrasound

OTHER

Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.

Device: Automated ultrasound

Interventions

Traditional ultrasound DEVICE

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

Handheld traditional ultrasound

Automated ultrasound DEVICE

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

Handheld Automated ultrasound

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Coagulopathy
• Low platelet count
• Allergies to local anesthetics

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (4)

• Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.

  PMID: 20696564 RESULT

• Carvalho B, Seligman KM, Weiniger CF. The comparative accuracy of a handheld and console ultrasound device for neuraxial depth and landmark assessment. Int J Obstet Anesth. 2019 Aug;39:68-73. doi: 10.1016/j.ijoa.2019.01.004. Epub 2019 Jan 11.

  PMID: 30770208 RESULT

• Weiniger CF, Carvalho B, Ronel I, Greenberger C, Aptekman B, Almog O, Kagan G, Shalev S. A randomized trial to investigate needle redirections/re-insertions using a handheld ultrasound device versus traditional palpation for spinal anesthesia in obese women undergoing cesarean delivery. Int J Obstet Anesth. 2022 Feb;49:103229. doi: 10.1016/j.ijoa.2021.103229. Epub 2021 Sep 23.

  PMID: 34670725 RESULT

• Seligman KM, Weiniger CF, Carvalho B. The Accuracy of a Handheld Ultrasound Device for Neuraxial Depth and Landmark Assessment: A Prospective Cohort Trial. Anesth Analg. 2018 Jun;126(6):1995-1998. doi: 10.1213/ANE.0000000000002407.

  PMID: 28858898 RESULT

Study Officials

• Antonio Gonzalez, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Gonzalez, MD

CONTACT

4133869415; Antonio.Gonzalez-fiol@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 18, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)