Study Stopped
We were unable to recruit subjects for this study.
Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients
Ultrasound Imaging Facilitates Lumbar Punctures in Pediatric Oncology Patients With Difficult Surface Landmarks and/or a History of Difficult Lumbar Puncture
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable leukemia
Started Jul 2012
Shorter than P25 for not_applicable leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 5, 2015
February 1, 2015
1.8 years
July 12, 2012
February 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of punctures
Number of punctures required to obtain cerebral spinal fluid.
1 day
Study Arms (1)
Ultrasound
EXPERIMENTALInterventions
Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.
Eligibility Criteria
You may qualify if:
- All patients undergoing LP as per Heme-Onc clinic who have been deemed to be difficult LP placements.
You may not qualify if:
- Patients having concomitant procedures (bone marrow bx, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (3)
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.
PMID: 19307389BACKGROUNDAbo 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.
PMID: 20403933BACKGROUNDAyalin 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. No abstract available.
PMID: 21496132BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 18, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 5, 2015
Record last verified: 2015-02