Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01643291
• Other study ID #: IRB12-00335
• Status: Terminated
• Phase: N/A
• First received: July 12, 2012
• Last updated: February 4, 2015
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

Intervention

Procedure:
• Ultrasound
Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of punctures	Number of punctures required to obtain cerebral spinal fluid.	1 day	No