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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317382
Recruitment Status : Terminated (We could not get physicians in the ED to enroll patients.)
First Posted : April 24, 2006
Last Update Posted : February 19, 2015
Information provided by:
St. Luke's-Roosevelt Hospital Center

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

Condition or disease Intervention/treatment Phase
Headache Meningitis Subarachnoid Hemorrhage Device: Ultrasound Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial
Study Start Date : December 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 3 or more needle sticks to successfully complete lumbar puncture [ Time Frame: We collect the data immediately ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00317382

United States, New York
St.Luke's-Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Principal Investigator: Kaushal Shah, MD St. Luke's-Roosevelt Hospital Center

Responsible Party: Emergency Physician, Columbia Univeristy College of Physicians & Surgeons Identifier: NCT00317382     History of Changes
Other Study ID Numbers: 03-148
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

Keywords provided by St. Luke's-Roosevelt Hospital Center:
lumbar puncture
traumatic tap

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases