Columbia University
New York, 10032, United States
NCT Number: NCT02373774
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.
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All sexes
Interventional
Not applicable
New York, 10032, United States
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).
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
Other names: (Zonare Z1.pro and/or Sonosite Mturbo)
Time frame: Outcome measured on the same day of the procedure
Our primary outcome of the clinical trial is binary, success or failure of lumbar puncture. Success is defined as obtaining a sample of cerebrospinal fluid on the first attempt that has a red blood cell count of <1000 red blood cells per high-powered field.
Time frame: Outcome measured at the time of the procedure (same day)
Defined as the number of times a lumbar puncture needle is removed from skin and reinserted or a new needle is inserted.
Columbia University
Other
Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture
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