Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04630171
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2020-11-12
Brief Title:
VerTouch Device A Prospective Randomized Controlled Trial
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
Thousands of neuraxial procedures are completed daily with over 12000 done at Prentice Womens 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None