Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?

February 18, 2015 updated by: St. Luke's-Roosevelt Hospital Center

Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial

Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a controlled trial randomizing lumbar puncture patients to groups utilizing ultrasound to preview the bony structures of the spine versus using standard palpation technique. The goal is to determine the helpfulness of ultrasound in performing lumbar punctures (to reduce difficult and traumatic lumbar punctures) among patients whose spines cannot be easily visualized.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St.Luke's-Roosevelt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 18
  • Clinical need for lumbar puncture
  • Unable to visualize spine in position for the lumbar puncture

Exclusion Criteria:

  • Able to visualize the spinous processes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Ultrasound
Standard LP without ultrasound use
Experimental: Ultrasound Use
Ultrasound used to assess spine and best location for lumbar puncture.
Device: Ultrasound
Ultrasound used to visualize spine to determine best location for lumbar puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 or more needle sticks to successfully complete lumbar puncture
Time Frame: We collect the data immediately
We collect the data immediately
Greater than 400 red blood cells in the cerebral spinal fluid
Time Frame: Data is obtained within 1 hour when the lab reports the results of the CSF analysis
Data is obtained within 1 hour when the lab reports the results of the CSF analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Investigators

  • Principal Investigator: Kaushal Shah, MD, St. Luke's-Roosevelt Hospital Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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