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

Mayo Clinic1 site in 1 country32 target enrollmentMay 25, 2017

ConditionsSpinal Puncture Diagnostic Imaging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spinal Puncture
Sponsor: Mayo Clinic
Enrollment: 32
Locations: 1
Primary Endpoint: Mean Procedural Duration
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 25, 2017

End Date

June 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Michael P Boniface

M.D., Principal Investigator

Mayo Clinic

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

Outcomes

Primary Outcomes

Mean Procedural Duration

Time Frame: Approximately 1 hour

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 Outcomes

Number of Procedures Considered to be Failures(Approximately 1 hour)
Patient reported discomfort(Approximately 1 day)
Hospital Length of Stay(Approximately 1 month)
Procedurist reported ease of the procedure(Approximately 1 day)
Number of Fluoroscopically Guided or CT Guided Lumbar Punctures(Approximately 7 days)
Total number of unique skin punctures(Approximately 1 day)
Number of red blood cells in collected CSF(Approximately 1 day)