Ultrasound Use for Difficult Lumbar Punctures in Pediatri... | NCT01643291

Studies
Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

NCT01643291

Sponsor

Nationwide Children's Hospital

Status

Terminated

Last Update Posted

Feb 5, 2015Estimated

Enrollment

3Actual

Phase

Not Applicable

Conditions

Leukemia

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 were unable to recruit subjects for this study.

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Jul 12, 2012

First Submission Date that Met QC Criteria

Jul 16, 2012

First Posted Date

Jul 18, 2012Estimated

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 4, 2015

Last Update Posted Date

Feb 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated radiation exposure. This investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.

Detailed Description

Not provided

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

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound	Experimental		Procedure: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Procedure	Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.	Ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of punctures	Number of punctures required to obtain cerebral spinal fluid.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing LP as per Heme-Onc clinic who have been deemed to be difficult LP placements.

Exclusion Criteria:

Patients having concomitant procedures (bone marrow bx, etc.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19307389	Background	Ferre RM, Sweeney TW, Strout TD. Ultrasound identification of landmarks preceding lumbar puncture: a pilot study. Emerg Med J. 2009 Apr;26(4):276-7. doi: 10.1136/emj.2007.057455.
20403933	Background	Abo A, Chen L, Johnston P, Santucci K. Positioning for lumbar puncture in children evaluated by bedside ultrasound. Pediatrics. 2010 May;125(5):e1149-53. doi: 10.1542/peds.2009-0646. Epub 2010 Apr 19.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation