Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
32 participants
INTERVENTIONAL
2017-05-25
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Control
Traditional landmark-based lumbar puncture technique by palpation
Traditional Landmark-based Lumbar Puncture
Palpation of anatomical landmarks to identify midline and interspinous space
Experimental (ultrasound)
Use of point-of-care ultrasound to identify bony landmarks.
Point-of-care ultrasound
A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.
Interventions
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Point-of-care ultrasound
A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.
Traditional Landmark-based Lumbar Puncture
Palpation of anatomical landmarks to identify midline and interspinous space
Eligibility Criteria
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Inclusion Criteria
2. Males or females 18 years of age or older
3. 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.
Exclusion Criteria
2. Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact.
3. 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.
4. BMI greater than 60
5. Absolute contraindication to lumbar puncture such as uncorrected coagulopathy
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael P Boniface
M.D., Principal Investigator
Principal Investigators
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Michael P Boniface, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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References
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Edwards C, Leira EC, Gonzalez-Alegre P. Residency training: a failed lumbar puncture is more about obesity than lack of ability. Neurology. 2015 Mar 10;84(10):e69-72. doi: 10.1212/WNL.0000000000001335.
Engedal TS, Ording H, Vilholm OJ. Changing the needle for lumbar punctures: results from a prospective study. Clin Neurol Neurosurg. 2015 Mar;130:74-9. doi: 10.1016/j.clineuro.2014.12.020. Epub 2015 Jan 6.
Ferre RM, Sweeney TW. Emergency physicians can easily obtain ultrasound images of anatomical landmarks relevant to lumbar puncture. Am J Emerg Med. 2007 Mar;25(3):291-6. doi: 10.1016/j.ajem.2006.08.013.
Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
Huang MY, Lin AP, Chang WH. Ultrasound-assisted localization for lumbar puncture in the ED. Am J Emerg Med. 2008 Oct;26(8):955-7. doi: 10.1016/j.ajem.2008.03.007. No abstract available.
Lahham S, Schmalbach P, Wilson SP, Ludeman L, Subeh M, Chao J, Albadawi N, Mohammadi N, Fox JC. Prospective evaluation of point-of-care ultrasound for pre-procedure identification of landmarks versus traditional palpation for lumbar puncture. World J Emerg Med. 2016;7(3):173-7. doi: 10.5847/wjem.j.1920-8642.2016.03.002.
Nomura JT, Leech SJ, Shenbagamurthi S, Sierzenski PR, O'Connor RE, Bollinger M, Humphrey M, Gukhool JA. A randomized controlled trial of ultrasound-assisted lumbar puncture. J Ultrasound Med. 2007 Oct;26(10):1341-8. doi: 10.7863/jum.2007.26.10.1341.
Peterson MA, Pisupati D, Heyming TW, Abele JA, Lewis RJ. Ultrasound for routine lumbar puncture. Acad Emerg Med. 2014 Feb;21(2):130-6. doi: 10.1111/acem.12305.
Williams S, Khalil M, Weerasinghe A, Sharma A, Davey R. How to do it: bedside ultrasound to assist lumbar puncture. Pract Neurol. 2017 Jan;17(1):47-50. doi: 10.1136/practneurol-2016-001463. Epub 2016 Nov 28.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-000511
Identifier Type: -
Identifier Source: org_study_id
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