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
  Purpose

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


Condition Intervention
Headache
Meningitis
Subarachnoid Hemorrhage
Device: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: December 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317382

Locations
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
Investigators
Principal Investigator: Kaushal Shah, MD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Emergency Physician, Columbia Univeristy College of Physicians & Surgeons
ClinicalTrials.gov Identifier: NCT00317382     History of Changes
Other Study ID Numbers: 03-148
Study First Received: April 20, 2006
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014