Ultrasound vs Palpation for Infant Lumbar Puncture

October 22, 2023 updated by: David Kessler, Columbia University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Device: Ultrasound
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measured on the same day of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measured at the time of the procedure (same day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Peter S Dayan, MD, MSc, Columbia University
  • Principal Investigator: David O Kessler, MD, MSc, Columbia University
  • Principal Investigator: Gerald Behr, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 7, 2015

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimated)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAO3705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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