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

Yale University

Status: Begins enrollment in 4 months

Conditions: Labor Analgesia

Treatments: Device: Automated ultrasound; Device: Traditional ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05909085

No NIH funding 09.05.23 (Other Identifier)

2000034863

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Handheld traditional ultrasound

Active Comparator group

Description:

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

Treatment:

Device: Traditional ultrasound

Handheld Automated ultrasound

Other group

Description:

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

Treatment:

Device: Automated ultrasound