NCT00317382

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

April 20, 2006

Last Update Submit

February 18, 2015

Conditions

HeadacheMeningitisSubarachnoid Hemorrhage

Keywords

lumbar punctureheadachetraumatic tap

Outcome Measures

Primary Outcomes (2)

  • 3 or more needle sticks to successfully complete lumbar puncture

    We collect the data immediately

  • 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

Study Arms (2)

No Ultrasound

NO INTERVENTION

Standard LP without ultrasound use

Ultrasound Use

EXPERIMENTAL

Ultrasound used to assess spine and best location for lumbar puncture.

Device: Ultrasound

Interventions

UltrasoundDEVICE

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

Ultrasound Use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18
  • Clinical need for lumbar puncture
  • Unable to visualize spine in position for the lumbar puncture

You may not qualify if:

  • Able to visualize the spinous processes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Luke's-Roosevelt Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

HeadacheMeningitisSubarachnoid Hemorrhage

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeuroinflammatory DiseasesNervous System DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kaushal Shah, MD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

December 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

US(1)