Neuraxial Ultrasound Device Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorStanford University
About this trial
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.
Eligibility criteria
Qualifiers
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.
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 70,000/μL, 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
Treatments tested in this trial
- Ultrasound placement device
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Stanford University
Lead sponsor
Rivanna Medical, Inc.
Collaborator
Source ClinicalTrials.gov