Ultrasound-Assisted Lumbar Puncture
- Conditions
- Spinal PunctureDiagnostic Imaging
- Interventions
- Procedure: Traditional Landmark-based Lumbar PunctureProcedure: Point-of-care ultrasound
- Registration Number
- NCT03167190
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. This study intends to see whether by using ultrasound there is increased success rate, decreased need for additional procedures, and less discomfort during the procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018
- Males or females 18 years of age or older
- Patients who have been identified as requiring a lumbar puncture for any therapeutic or diagnostic or therapeutic indication, as decided by the neurology staff physicians, residents, or advanced practice providers.
- Patients who are not capable of providing consent for participation in research and do not have an authorized relative or power of attorney to consent in their stead.
- Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact.
- Patients with known abnormal lumbar spinal anatomy or prior extensive surgical fusion such that fluoroscopic or CT guidance is determined to be more clinically appropriate by the treating physicians.
- BMI greater than 60
- Absolute contraindication to lumbar puncture such as uncorrected coagulopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Traditional Landmark-based Lumbar Puncture Traditional landmark-based lumbar puncture technique by palpation Experimental (ultrasound) Point-of-care ultrasound Use of point-of-care ultrasound to identify bony landmarks.
- Primary Outcome Measures
Name Time Method Mean Procedural Duration Approximately 1 hour This is defined by number of minutes from initiating of patient positioning (prior to evaluation of the anatomical landmarks) to first flow of cerebrospinal fluid (CSF).
- Secondary Outcome Measures
Name Time Method Number of Procedures Considered to be Failures Approximately 1 hour As defined by inability to obtain cerebrospinal fluid despite multiple attempts, terminated at the discretion of the procedurist as would otherwise be clinically determined.
Patient reported discomfort Approximately 1 day Patient reported discomfort will be reported by a 10 cm visual analog scale, with 0=no discomfort and 10=extreme discomfort.
Hospital Length of Stay Approximately 1 month This will be abstracted manually from the patient's electronic medical record.
Procedurist reported ease of the procedure Approximately 1 day Procedurist reported ease of the procedure will be reported by a 10 cm visual analog scale, with 0=easy and 10=very difficult.
Number of Fluoroscopically Guided or CT Guided Lumbar Punctures Approximately 7 days In the event of ultrasound procedural failure by clinician
Total number of unique skin punctures Approximately 1 day This will be defined by the needle bevel completely exiting and skin and being re-inserted, during the duration of the procedure, whether the procedure is ultimately successful or not.
Number of red blood cells in collected CSF Approximately 1 day This will be abstracted manually from the patient's electronic medical record.
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States