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Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

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ClinicalTrials.gov Identifier: NCT01643291
Recruitment Status : Terminated (We were unable to recruit subjects for this study.)
First Posted : July 18, 2012
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Leukemia Procedure: Ultrasound

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ultrasound Procedure: Ultrasound
Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.


Outcome Measures

Primary Outcome Measures :
  1. Number of punctures [ Time Frame: 1 day ]
    Number of punctures required to obtain cerebral spinal fluid.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643291


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