Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

This study has been terminated.
(We were unable to recruit subjects for this study.)
Sponsor:
Information provided by (Responsible Party):
Tarun Bhalla, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01643291
First received: July 12, 2012
Last updated: February 4, 2015
Last verified: February 2015
  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:


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.


Enrollment: 3
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: February 4, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015