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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices

Conditions
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Labor Analgesia

Intervention / Treatment
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* Device: Traditional ultrasound
* Device: Automated ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Handheld traditional ultrasound<br>Traditional US will be used to compare number of needle manipulations to the handheld US. | Device: Traditional ultrasound<br>* Labor epidural will be performed after marking patient skin using traditional ultrasound guidance<br>|
| Other: Handheld Automated ultrasound<br>Automated device provides automatic information pertaining to distance to epidural space distance and interspace location. | Device: Automated ultrasound<br>* Labor epidural will be performed after marking patient skin using an automated ultrasound device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Needle attempts | Number of times the needle is advanced in and out of the skin | 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 from placing ultrasound on patients back until markings are complete | 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 from placing ultrasound on patients back until markings are complete | 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 | Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance | Up to 60 minutes | 
| Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance | 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. | Up to 60 minutes | 
| Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance | 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. | Up to 60 minutes | 
| Patient satisfaction | 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 | 15 - 20 minutes after epidural placement |