Accuracy of the Accuro 3S
ConditionNeuraxial Technique
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ACCURO 3S
DeviceProvides anatomical guidance during the placement of needles or catheters using real-time visualization.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Standard of Care and neuraxial guidanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean number of needle attempts
Defined as the number of times the needle is inserted into patients back
Time frame
At time of procedure, 1 day2
Mean number of needle redirections
Defined as number of needle movements in a cephalad, caudal or lateral position.
Time frame
At time of procedure, 1 day3
Accuracy of device
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).
Time frame
At time of procedure, 1 daySecondary outcomes
1
Patient satisfaction
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.
Time frame
20 minutes post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Rivanna Medical, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: