Ultrasound-Assisted Lumbar Puncture

NCT03167190 | Terminated

• 1 other identifier: 17-000511
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Puncture; Diagnostic Imaging

Keywords

Point of Care Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Number of Procedures Considered to be Failures

  Approximately 1 hour

• Number of Fluoroscopically Guided or CT Guided Lumbar Punctures

  Approximately 7 days

• Total number of unique skin punctures

  Approximately 1 day

• Procedurist reported ease of the procedure

  Approximately 1 day

• Patient reported discomfort

  Approximately 1 day

Study Arms (2)

Control

OTHER

Traditional landmark-based lumbar puncture technique by palpation

Procedure: Traditional Landmark-based Lumbar Puncture

Experimental (ultrasound)

EXPERIMENTAL

Use of point-of-care ultrasound to identify bony landmarks.

Procedure: Point-of-care ultrasound

Interventions

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.

Experimental (ultrasound)

Traditional Landmark-based Lumbar Puncture PROCEDURE

Palpation of anatomical landmarks to identify midline and interspinous space

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (9)

• 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.

  PMID: 25754807 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.

  PMID: 25590665 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.

  PMID: 17349903 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.

  PMID: 11172514 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.

  PMID: 18926360 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.

  PMID: 27547275 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.

  PMID: 17901137 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.

  PMID: 24673668 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.

  PMID: 27895189 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Michael P Boniface, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 25, 2017
• Study Start: May 25, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)