Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

February 4, 2015 updated by: Tarun Bhalla, MD, Nationwide Children's Hospital

Ultrasound Imaging Facilitates Lumbar Punctures in Pediatric Oncology Patients With Difficult Surface Landmarks and/or a History of Difficult Lumbar Puncture

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • IRB12-00335

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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