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

Not Applicable

Not yet recruiting

• Conditions: Labor Analgesia
• Interventions: Device: Traditional ultrasound; Device: Automated ultrasound

• Registration Number: NCT05909085
• Lead Sponsor: Yale University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Study Start: 2025-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Handheld traditional ultrasound	Traditional ultrasound	Traditional US will be used to compare number of needle manipulations to the handheld US.
Handheld Automated ultrasound	Automated ultrasound	Automated device provides automatic information pertaining to distance to epidural space distance and interspace location.

Primary Outcome Measures

Name	Time	Method
Number of needle passes	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 Outcome Measures

Name	Time	Method
Number of Needle attempts	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
Time from local anesthetic injection till time of epidural space identification	Up to 60 minutes	Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance
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 from placing ultrasound on patients back until markings are complete
Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance	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.
Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance	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.
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 placing ultrasound on patients back until markings are complete
Patient satisfaction	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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States