Does Static Ultrasound-Preview Reduce the Incidence of Di... | NCT00317382

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

NCT00317382

Sponsor

St. Luke's-Roosevelt Hospital Center

Status

Terminated

Last Update Posted

Feb 19, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Headache
Meningitis
Subarachnoid Hemorrhage

Interventions

Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We could not get physicians in the ED to enroll patients.

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Apr 20, 2006

First Submission Date that Met QC Criteria

Apr 20, 2006

First Posted Date

Apr 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2015

Last Update Posted Date

Feb 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device	Ultrasound used to visualize spine to determine best location for lumbar puncture.	Ultrasound Use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kaushal Shah, MD	St. Luke's-Roosevelt Hospital Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St.Luke's-Roosevelt Hospital		New York	New York	10025	United States

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D008581	Meningitis
D013345	Subarachnoid Hemorrhage

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided