Clinical trial NCT03167190: Ultrasound-Assisted Lumbar Puncture
Official title: Ultrasound-localized Landmark Identification in Hospitalized Patients Requiring Lumbar Puncture: Implications for Safety, Quality, and Procedural Success
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Puncture
Diagnostic Imaging
Keywords: Point of Care Ultrasound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018
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:

1. 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.
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

Primary outcomes:
measure: Mean Procedural Duration
timeFrame: Approximately 1 hour
Secondary outcomes:
measure: Number of Procedures Considered to be Failures
timeFrame: Approximately 1 hour
measure: Number of Fluoroscopically Guided or CT Guided Lumbar Punctures
timeFrame: Approximately 7 days
measure: Total number of unique skin punctures
timeFrame: Approximately 1 day
measure: Procedurist reported ease of the procedure
timeFrame: Approximately 1 day
measure: Patient reported discomfort
timeFrame: Approximately 1 day
measure: Number of red blood cells in collected CSF
timeFrame: Approximately 1 day
measure: Hospital Length of Stay
timeFrame: Approximately 1 month
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael P Boniface, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.