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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Provides anatomical guidance during the placement of needles or catheters using real-time visualization.
Yale New Haven Hospital
New Haven, Connecticut, United States
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 day
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 day
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 day
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 procedure
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