Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

• Sponsor: Nationwide Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01643291
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.1

Study Details

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	Phase
Leukemia	Procedure: Ultrasound	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• 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: Jul 1, 2012
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

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 [1 day]

   Number of punctures required to obtain cerebral spinal fluid.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. doi: 10.1542/peds.2009-0646. 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.
• 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. doi: 10.1136/emj.2007.057455.

• Responsible Party: Tarun Bhalla, MD, Assistant Professor, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT01643291
• Other Study ID Numbers: IRB12-00335
• First Posted: Jul 18, 2012
• Last Update Posted: Feb 5, 2015
• Last Verified: Feb 1, 2015

Study Results

No Results Posted as of Feb 5, 2015