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

This study has been terminated.
(We could not get physicians in the ED to enroll patients.)
Sponsor:
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00317382
First received: April 20, 2006
Last updated: July 23, 2010
Last verified: July 2010
History of Changes

April 20, 2006
July 23, 2010
December 2004
October 2005   (final data collection date for primary outcome measure)
  • 3 or more needle sticks to successfully complete lumbar puncture [ Time Frame: We collect the data immediately ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 3 or more needle sticks to successfully complete lumbar puncture
  • Greater than 400 reb blood cells in the cerebral spinal fluid
Complete list of historical versions of study NCT00317382 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?
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?

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Headache
  • Meningitis
  • Subarachnoid Hemorrhage
Device: Ultrasound
Ultrasound used to visualize spine to determine best location for lumbar puncture.
  • No Intervention: No Ultrasound
    Standard LP without ultrasound use
  • Experimental: Ultrasound Use
    Ultrasound used to assess spine and best location for lumbar puncture.
    Intervention: Device: Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00317382
03-148
Yes
Emergency Physician, Columbia Univeristy College of Physicians & Surgeons
St. Luke's-Roosevelt Hospital Center
Not Provided
Principal Investigator: Kaushal Shah, MD St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP