Back to resultsDoes Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?
Primary Purpose
Headache, Meningitis, Subarachnoid Hemorrhage
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Headache focused on measuring lumbar puncture, headache, traumatic tap
Eligibility 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
Sites / Locations
- St.Luke's-Roosevelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Ultrasound
Ultrasound Use
Arm Description
Standard LP without ultrasound use
Ultrasound used to assess spine and best location for lumbar puncture.
Outcomes
Primary Outcome Measures
3 or more needle sticks to successfully complete lumbar puncture
Greater than 400 red blood cells in the cerebral spinal fluid
Secondary Outcome Measures
Full Information
NCT ID
NCT00317382
First Posted
April 20, 2006
Last Updated
February 18, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT00317382
Brief Title
Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?
Official Title
Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
We could not get physicians in the ED to enroll patients.
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Meningitis, Subarachnoid Hemorrhage
Keywords
lumbar puncture, headache, traumatic tap
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Ultrasound
Arm Type
No Intervention
Arm Description
Standard LP without ultrasound use
Arm Title
Ultrasound Use
Arm Type
Experimental
Arm Description
Ultrasound used to assess spine and best location for lumbar puncture.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound used to visualize spine to determine best location for lumbar puncture.
Primary Outcome Measure Information:
Title
3 or more needle sticks to successfully complete lumbar puncture
Time Frame
We collect the data immediately
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaushal Shah, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Luke's-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
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Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?
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