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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA-1, ASA-2, and ASA-3

Patients with no known back deformities

Ability to sit upright for epidural placement

No prior lumbar surgery

Disqualifiers

Coagulopathy

Low platelet count

Allergies to local anesthetics

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Handheld traditional ultrasoundActive comparator 1 intervention
Group B: Handheld Automated ultrasoundOther 1 intervention

Trial outcomes

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.

Time frame
From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes

Secondary outcomes

1

Number of Needle attempts

Number of times the needle is advanced in and out of the skin

Time frame
From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
2

Time to obtain ultrasound images with traditional ultrasound device

Time from placing ultrasound on patients back until markings are complete

Time frame
Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
3

Time to obtain images with automated ultrasound device

Time from placing ultrasound on patients back until markings are complete

Time frame
Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
4

Time from local anesthetic injection till time of epidural space identification

Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance

Time frame
Up to 60 minutes

Other outcomes

Sponsors and contacts

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