Ultrasound-Assisted Lumbar Puncture

Diagnostic Imaging Clinical Trial

Official title:

Ultrasound-localized Landmark Identification in Hospitalized Patients Requiring Lumbar Puncture: Implications for Safety, Quality, and Procedural Success

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03167190
• Other study ID #: 17-000511
• Status: Terminated
• Phase: N/A
• Start date: May 25, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Imaging
• Spinal Puncture
• Wounds and Injuries

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Engedal TS, Ørding 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Fluoroscopically Guided or CT Guided Lumbar Punctures	In the event of ultrasound procedural failure by clinician	Approximately 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of red blood cells in collected CSF	This will be abstracted manually from the patient's electronic medical record.	Approximately 1 day
Secondary	Hospital Length of Stay	This will be abstracted manually from the patient's electronic medical record.	Approximately 1 month

External Links

•   Mayo Clinic Clinical Trials