Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Tarun Bhalla, MD, Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT01643291

First received: July 12, 2012

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Purpose

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.

Condition	Intervention
Leukemia	Procedure: Ultrasound

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ultrasound Imaging Facilitates Lumbar Punctures in Pediatric Oncology Patients With Difficult Surface Landmarks and/or a History of Difficult Lumbar Puncture

Resource links provided by NLM:

MedlinePlus related topics: Leukemia

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:

Number of punctures [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Number of punctures required to obtain cerebral spinal fluid.

Estimated Enrollment:	50
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ultrasound	Procedure: Ultrasound Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643291

Locations

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

More Information

Publications:

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.

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. Epub 2010 Apr 19.

Ayalin T, Lam SH. Ultrasound-assisted lumbar puncture in infants. Acad Emerg Med. 2011 Apr;18(4):e36. doi: 10.1111/j.1553-2712.2011.01044.x.

Responsible Party:	Tarun Bhalla, MD, Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT01643291 History of Changes
Other Study ID Numbers:	IRB12-00335
Study First Received:	July 12, 2012
Last Updated:	July 16, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013

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