Real-time Spine Ultrasound Imaging System: Data Collection Study
Stanford University
Summary
The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.
Description
This is a prospective, structured observational study (data collection study) in which Investigators enroll patients who are scheduled for neuraxial anesthesia procedures. Qualified subjects will be identified and contacted by the anesthesia team prior to their clinical evaluation for labor neuraxial analgesia. Potential patients will be informed of the study, and if study individuals choose to participate and an informed consent form will be signed prior to any study related activities. When study participants request labor analgesia, investigators will incorporate routine care delivery flo…
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Aged 18 years or older * The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure. * Patient skin is intact in the area of placement of the epidural or spinal anesthesia. 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…
Interventions
- DeviceUltrasound placement device
Device to assist in placement of epidural procedure
Location
- Stanford UniversityStanford, California