Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

Study Overview
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Brief Summary
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The purpose of this study is to determine if a handheld ultrasound device helps in the placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound device compared to a standard ultrasound machine.

Detailed Description
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Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Ultrasound evaluations will be conducted in a cohort of 50 parturients who decide they want epidural analgesia in labor. Prior to epidural placement, a hand held ultrasound device will be utilized to identify L2/3, L3/4 and L4/5 interspace. A mark will be made on the patient's back at these levels. The handheld ultrasound device will also estimate the depth to epidural space at each level using its programmed algorithm. A standard ultrasound will then be used to locate the same interspaces, identify midline, and estimate depth to epidural space with caliper calculation. Upon patient request, an epidural will be placed at L3/4 with a loss of resistance to saline technique. The actual depth to loss of resistance during epidural insertion will be determined by measuring the Tuohy with a sterile measuring tape while it is in the skin.

Official Title
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Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Accuro Handheld Ultrasound
* Device: Standard Ultrasound Machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status class I, II, or III age between 18 and 50 singleton term pregnancy requesting epidural analgesia for anticipated vaginal delivery all ethnicities Exclusion Criteria: contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy) inability to adequately understand the consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Accuro Handheld Ultrasound|Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space|
|Device: Standard Ultrasound Machine|Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth to Epidural Space | Determine the difference between the Accuro ultrasound epidural space depth estimation and actual Tuohy epidural depth during epidural insertion at L3/4 | Within 24 Hours of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Midline Identification | The difference between the Accuro Handheld Ultrasound identification of midline and standard ultrasound machine identification of midline | Within 24 Hours of enrollment | 
| Interspace Identification | The difference between the Accuro Handheld Ultrasound identification of interspace level and standard ultrasound identification of interspace level | Within 24 Hours of enrollment | 
| Time to Epidural Placement | Specifically time from insertion of the Tuohy into the skin until removal of the Tuohy after epidural catheter threading | Within 24 Hours of enrollment | 
| Interspace Levels Attempts | Number of interspace levels attempts for epidural placement | Within 24 Hours of enrollment | 
| Epidural Failure Rate | Need for replacement epidural or change in anesthetic technique | Within 24 Hours of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuraxial, Ultrasound