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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Traditional landmark-based lumbar puncture technique by palpation |
|
| Experimental (ultrasound) | Experimental | Use of point-of-care ultrasound to identify bony landmarks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care ultrasound | Procedure | A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Procedural Duration | 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). | Approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Procedures Considered to be Failures | As defined by inability to obtain cerebrospinal fluid despite multiple attempts, terminated at the discretion of the procedurist as would otherwise be clinically determined. | Approximately 1 hour |
| Number of Fluoroscopically Guided or CT Guided Lumbar Punctures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Boniface, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25754807 | Background | 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. | |
| 25590665 | Background | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Participants will be enrolled into the control group (Landmark-based palpation and skin marking) vs the experimental group (ultrasound assisted identification of bony landmarks and skin marking).
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| Traditional Landmark-based Lumbar Puncture | Procedure | Palpation of anatomical landmarks to identify midline and interspinous space |
|
In the event of ultrasound procedural failure by clinician |
| Approximately 7 days |
| Total number of unique skin punctures | 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. | Approximately 1 day |
| Procedurist reported ease of the procedure | Procedurist reported ease of the procedure will be reported by a 10 cm visual analog scale, with 0=easy and 10=very difficult. | Approximately 1 day |
| Patient reported discomfort | Patient reported discomfort will be reported by a 10 cm visual analog scale, with 0=no discomfort and 10=extreme discomfort. | Approximately 1 day |
| Number of red blood cells in collected CSF | This will be abstracted manually from the patient's electronic medical record. | Approximately 1 day |
| Hospital Length of Stay | This will be abstracted manually from the patient's electronic medical record. | Approximately 1 month |
| 17349903 | Background | 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. |
| 11172514 | Background | 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. |
| 18926360 | Background | 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. |
| 27547275 | Background | 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. |
| 17901137 | Background | 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. |
| 24673668 | Background | 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. |
| 27895189 | Background | 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. |