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OpenTrials
Completed

NCT Number: NCT02373774

Ultrasound vs Palpation 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.

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Key information

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

About this study

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).

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

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)

Primary outcomes

  1. Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts

    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.

Secondary outcomes

  1. Number of Attempts- Per Direct Observation

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2015
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.