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Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital Identifier:
First received: July 12, 2012
Last updated: July 25, 2013
Last verified: July 2013

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
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:

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 2014
Estimated Primary Completion Date: June 2014 (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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01643291

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

Responsible Party: Tarun Bhalla, MD, Assistant Professor, Nationwide Children's Hospital Identifier: NCT01643291     History of Changes
Other Study ID Numbers: IRB12-00335
Study First Received: July 12, 2012
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board processed this record on November 24, 2014