VerTouch Device: A Prospective Randomized Controlled Trial

Study Overview
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Brief Summary
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This study will compare the VerTouch device to palpation and ultrasound (US) techniques used to identifying the anatomic landmarks and optimal location for neuraxial access. This trial of the VerTouch device will be compared to the gold standard of palpatoin and the commonly cited US techniques.

Detailed Description
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Thousands of neuraxial procedures are completed daily with over 12,000 done at Prentice Women's hospital last year. These procedures are not without difficulty and complication. The gold standard of palpation and blind advancement of the needle toward the spine can result in multiple insertions of the needle into the skin and redirections of the trajectory of that needle after insertion to avoid the bones of the spine protecting the spinal column. These insertions and redirections are not only time consuming while the patient is in an uncommon position, but they also cause dis-comfort and possibly lasting pain days after the procedure. In addition to the patient dynamics, when anatomical or positioning issues result in difficult neuraxial procedures the common teaching is to attempt US guided access. Unfortunately, not many proceduralist are trained in this modality and the additional materials needed to perform the procedure with US take time to gather and further prolong the procedure. Additionally, though the cost of US technology is getting more reasonable, it is still rather expensive and a barrier to utilization by many facilities around the country and the world. Often, after many attempts, the proceduralist accepts failure of the procedure and refers the patient to the interventional radiology (IR) or pain medicine specialist for completion of the procedure using radiation to visualize the spine. Note, this is not an option for pregnant women who are not eligible for radiation due to fetal concerns. The VerTouch device offers a non-invasive, untethered, and non-radiation producing device that allows for the visualization of the underlying structures of the spine to determine ideal needle placement for neuraxial procedures. The output on the screen can also be visualized by other providers or senior proceduralist for assistance with best course of action for the procedure. The device does not cause discomfort to the patient and does not require any additional materials to be functional. Study participants will be recruited in two parallel cohorts (pregnant patients and non-pregnant patients). Pregnant patients tend to be healthy and without comorbidities, and the anesthesiologists who perform the neuraxial procedure tend to have significant experience. Non-pregnant patients tend to require neuraxial access for diagnostic or therapeutic purposes (i.e. not for the relief of labor pains), and therefore have comorbidities. Labor & Delivery: Participants will be randomized to one of the three arms (palpation, US, or VerTouch). Lumbar Puncture: Participants will be randomized to one of the three arms (palpation, US, or VerTouch). This study has the potential to show that the VerTouch is more effective than palpation and as effective as US at defining the location for neuraxial procedure initiation and eventual success.

Official Title
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Does the VerTouch Device Improve Insertion Site Identification for Lumbar Neuraxial Procedures When Compared to Palpation or Ultrasound Guided Site Selection? A Prospective Randomized Controlled Trial

Conditions
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Pregnancy, Pain

Intervention / Treatment
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* Device: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure
* Device: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure
* Other: Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure
* Device: Group #4: VerTouch utilized for identification of site for lumbar puncture procedure
* Device: Group #5: Ultrasound (US) utilized for identification of site for lumbar puncture procedure
* Other: Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 18 years old and above Undergoing a neuraxial procedure Exclusion Criteria: Non English speaking Plastic allergy Unable to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Prospective randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: VerTouch for labor epidural or spinal anesthesia procedure<br>VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. | Device: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure<br>* Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia<br>* Other names: Group 1;|
| Active Comparator: Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure<br>Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. | Device: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure<br>* Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia<br>* Other names: Group 2;|
| Active Comparator: Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure<br>Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia. | Other: Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure<br>* Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia<br>* Other names: Group 3;|
| Experimental: Group 4: VerTouch for lumbar puncture procedure<br>VerTouch utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture. | Device: Group #4: VerTouch utilized for identification of site for lumbar puncture procedure<br>* Group #4: VerTouch utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture<br>* Other names: Group 4;|
| Active Comparator: Group 5: Ultrasound (US) for lumbar puncture procedure<br>Ultrasound (US) utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture. | Device: Group #5: Ultrasound (US) utilized for identification of site for lumbar puncture procedure<br>* Ultrasound (US) utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture<br>* Other names: Group 5;|
| Active Comparator: Group 6: Control group, palpation for lumbar puncture procedure<br>Control group, palpation utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture. | Other: Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure<br>* Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture<br>* Other names: Group 6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of insertions of the needle | Primary endpoint is the number of insertions of the needle | End of procedure | 
| Number of redirections of the needle | Primary endpoint is the number of redirections of the needle | End of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Lumbar Puncture, Ultrasound, Labor epidural, Spinal Procedure, Pregnancy, Neuraxial Anesthesia