Ultrasound vs Palpation for Infant Lumbar Puncture



Status:Recruiting
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:July 2015
End Date:August 2016
Contact:David O Kessler, MD, MSc
Email:dk2592@columbia.edu
Phone:212-305-9825

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Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture

The purpose of this study is to determine if performing an ultrasound to identify the space
to insert the needle before performing a lumbar puncture will improve success of the
procedure and patient safety.

The investigators are conducting a single-center, prospective two-arm parallel group
randomized clinical trial in an urban pediatric emergency department to determine if
performing an ultrasound prior to lumbar puncture procedure improves success of the
procedure.

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.

Inclusion Criteria:

- Patient is less than 90 days old.

- Patient is receiving a lumbar puncture

Exclusion Criteria:

- Patient is clinically unstable

- 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
We found this trial at
1
site
NY, New York 10032
Phone: 212-305-9825
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