Neuraxial Technique
Conditions
Keywords
regional anesthesia/analgesia, spinal anesthesia, epidural
Brief summary
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural). The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Detailed description
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
Interventions
DEVICEACCURO 3S
Provides anatomical guidance during the placement of needles or catheters using real-time visualization.
Sponsors
Yale University
Rivanna Medical, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Anticipated 10 spinal and 40 epidural procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* The anesthetic plan for the patient includes a neuraxial anesthetic (spinal or epidural) as the main anesthetic for labor, surgery (e.g. orthopedic surgery, cesarean delivery) or for postoperative pain management (e.g, major abdominal surgery). \*Given our labor and delivery volume (\~300 epidurals/month) investigators think that they will only recruitc obstetric patients. In case of difficulty recruiting, then investigators will seek out a different patient population. * No history of allergic reactions to adhesives used in standard epidural placements as per chart review or self-reported. * Patient skin is intact in the area of placement of the epidural or spinal anesthesia. * The patient is English speaking. * For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor. \*Clarification - Patients scheduled for elective cesarean delivery will be approached for spinal anesthesia. Given that spinal anesthesia carries a smaller risk for post-dural puncture headache and other morbidities, investigators will recruit and perform 10 spinals on this patient population. Once comfortable with the technology, then will move to recruiting and performing epidurals. If during the spinal anesthesia trial the device does not provide accurate and clear needle visualization, the study will be culminated.
Exclusion criteria
* Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100, 000, or evidence of infection at potential epidural site. * Presence of orthopedic implants in the spine. * Skin dyscrasias or allergies to the ultrasound procedure. * Unable to assume sitting position. * Body Mass Index (BMI) less than 18.5 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of needle attempts | At time of procedure, 1 day | Defined as the number of times the needle is inserted into patients back |
| Mean number of needle redirections | At time of procedure, 1 day | Defined as number of needle movements in a cephalad, caudal or lateral position. |
| Accuracy of device | At time of procedure, 1 day | The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 20 minutes post procedure | Likert scale asking the patient "How satisfied are you with the procedure performed?" Very dissatisfied, dissatisfied, Satisfied, very satisfied, extremely satisfied. Total score range 1-5 with higher scores indicating more satisfaction. |
Countries
United States
Contacts
CONTACTAntonio Gonzalez-Fiol, MD
PRINCIPAL_INVESTIGATORAntonio Gonzalez-Fiol, MD
Yale University
Outcome results
None listed