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NCT00317382 Clinical Trial

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

Headache Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00317382
Other study ID # 03-148
Secondary ID
Status Terminated
Phase N/A
First received April 20, 2006
Last updated February 18, 2015
Start date December 2004
Est. completion date October 2005

Study information
Verified date February 2015
Source St. Luke's-Roosevelt Hospital Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 60
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Ultrasound
Ultrasound used to visualize spine to determine best location for lumbar puncture.

Locations
Country Name City State
United States St.Luke's-Roosevelt Hospital New York New York

Sponsors (1)
Lead Sponsor Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 3 or more needle sticks to successfully complete lumbar puncture We collect the data immediately No
Primary Greater than 400 red blood cells in the cerebral spinal fluid Data is obtained within 1 hour when the lab reports the results of the CSF analysis No
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