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Ultrasound-Assisted Lumbar Puncture

Primary Purpose

Spinal Puncture, Diagnostic Imaging

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Point-of-care ultrasound

Traditional Landmark-based Lumbar Puncture

About this trial

This is an interventional diagnostic trial for Spinal Puncture focused on measuring Point of Care Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Experimental (ultrasound)

Arm Description

Traditional landmark-based lumbar puncture technique by palpation

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Number of Fluoroscopically Guided or CT Guided Lumbar Punctures

In the event of ultrasound procedural failure by clinician

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.

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.

Patient reported discomfort

Patient reported discomfort will be reported by a 10 cm visual analog scale, with 0=no discomfort and 10=extreme discomfort.

Number of red blood cells in collected CSF

This will be abstracted manually from the patient's electronic medical record.

Hospital Length of Stay

This will be abstracted manually from the patient's electronic medical record.

Full Information

NCT ID

NCT03167190

First Posted

May 24, 2017

Last Updated

January 6, 2020

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03167190

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

Failed to meet target enrollment

Study Start Date

May 25, 2017 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Puncture, Diagnostic Imaging

Keywords

Point of Care Ultrasound

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

Participant

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Other

Arm Description

Traditional landmark-based lumbar puncture technique by palpation

Arm Title

Experimental (ultrasound)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Point-of-care ultrasound

Intervention Description

A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.

Intervention Type

Procedure

Intervention Name(s)

Traditional Landmark-based Lumbar Puncture

Intervention Description

Palpation of anatomical landmarks to identify midline and interspinous space

Primary Outcome Measure Information:

Title

Mean Procedural Duration

Description

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).

Time Frame

Approximately 1 hour

Secondary Outcome Measure Information:

Title

Number of Procedures Considered to be Failures

Description

As defined by inability to obtain cerebrospinal fluid despite multiple attempts, terminated at the discretion of the procedurist as would otherwise be clinically determined.

Time Frame

Approximately 1 hour

Title

Number of Fluoroscopically Guided or CT Guided Lumbar Punctures

Description

In the event of ultrasound procedural failure by clinician

Time Frame

Approximately 7 days

Title

Total number of unique skin punctures

Description

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.

Time Frame

Approximately 1 day

Title

Procedurist reported ease of the procedure

Description

Procedurist reported ease of the procedure will be reported by a 10 cm visual analog scale, with 0=easy and 10=very difficult.

Time Frame

Approximately 1 day

Title

Patient reported discomfort

Description

Patient reported discomfort will be reported by a 10 cm visual analog scale, with 0=no discomfort and 10=extreme discomfort.

Time Frame

Approximately 1 day

Title

Number of red blood cells in collected CSF

Description

This will be abstracted manually from the patient's electronic medical record.

Time Frame

Approximately 1 day

Title

Hospital Length of Stay

Description

This will be abstracted manually from the patient's electronic medical record.

Time Frame

Approximately 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael P Boniface, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25754807

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.

Results Reference

background

PubMed Identifier

25590665

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.

Results Reference

background

PubMed Identifier

17349903

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.

Results Reference

background

PubMed Identifier

11172514

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.

Results Reference

background

PubMed Identifier

18926360

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.

Results Reference

background

PubMed Identifier

27547275

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.

Results Reference

background

PubMed Identifier

17901137

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.

Results Reference

background

PubMed Identifier

24673668

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.

Results Reference

background

PubMed Identifier

27895189

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.

Results Reference

background

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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Ultrasound-Assisted Lumbar Puncture

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