Study Results
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View full resultsBasic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2015-07-31
2016-07-31
Brief Summary
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Detailed Description
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Patients will be block-randomized into two groups to receive procedural interspace selection via 1) standard anatomic palpation technique or 2) visualization with pre-procedural ultrasound (experimental group).
1. Standard Anatomic Palpation Technique:
Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace. As variations on the palpation technique exist, the investigators will provide a standardized educational cognitive aid that clinicians can use for this approach.
2. Pre-Procedural Ultrasound:
Clinicians will first use the standard palpation technique to select an interspace for ultrasound evaluation. A select group of pediatric emergency medicine attendings and fellows who have already trained to a mastery standard with the ultrasound protocol will then conduct the pre-procedural ultrasound. The clinicians performing the lumbar puncture will be provided the following information to conduct the lumbar puncture:
i. Assessment for fluid at the level selected (and the number of interspaces above that have fluid without conus present)
ii. Measurements of appropriate angle and depth
iii. Evaluation of any overlying vasculature
Post-Lumbar Puncture:
After the lumbar puncture, infants randomized to both groups will receive a post-procedural ultrasound scan performed by one of the mastery trained ultrasound physicians.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Standard Anatomic Palpation Technique
Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace to perform lumbar puncture.
No interventions assigned to this group
Pre-Procedural Ultrasound
Participants randomized to this group will receive an ultrasound of the interspace selected via the palpation method prior to performance of the lumbar puncture to determine measurements of appropriate angle and depth and evaluation of any overlying vasculature.
Ultrasound
Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
Interventions
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Ultrasound
Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is receiving a lumbar puncture
Exclusion Criteria
* Patient had a previous lumbar puncture in the past 24 hours
* An outside consultant (not working in ED) is performing the LP
* Patient has developmental delay or neurological impairment
* There is no legal guardian present
* The legal guardians speak neither English nor Spanish
* There is no ultrasound personnel available to enroll
90 Days
ALL
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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David Kessler
Assistant Professor
Principal Investigators
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David O Kessler, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Gerald Behr, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Peter S Dayan, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Columbia University
New York, New York, United States
Countries
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References
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Glatstein MM, Zucker-Toledano M, Arik A, Scolnik D, Oren A, Reif S. Incidence of traumatic lumbar puncture: experience of a large, tertiary care pediatric hospital. Clin Pediatr (Phila). 2011 Nov;50(11):1005-9. doi: 10.1177/0009922811410309. Epub 2011 May 27.
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Lo MD, Parisi MT, Brown JC, Klein EJ. Sitting or tilt position for infant lumbar puncture does not increase ultrasound measurements of lumbar subarachnoid space width. Pediatr Emerg Care. 2013 May;29(5):588-91. doi: 10.1097/PEC.0b013e31828e630d.
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Wilson DA, Prince JR. John Caffey award. MR imaging determination of the location of the normal conus medullaris throughout childhood. AJR Am J Roentgenol. 1989 May;152(5):1029-32. doi: 10.2214/ajr.152.5.1029.
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Other Identifiers
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AAAO3705
Identifier Type: -
Identifier Source: org_study_id
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