Ultrasound vs Palpation for Infant Lumbar Puncture

Not Applicable

Completed

• Conditions: Spinal; Puncture, Complications
• Interventions: Device: Ultrasound

• Registration Number: NCT02373774
• Lead Sponsor: Columbia University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-02-07
• Study First Submitted QC: 2015-02-22
• Study First Posted: 2015-02-27
• Study Start: 2015-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2019-03-03
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-22
• Last Update Submitted: 2023-10-22
• Results First Posted: 2023-10-24
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Patient is less than 90 days old.
• Patient is receiving a lumbar puncture

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Procedural Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts	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 Outcome Measures

Name	Time	Method
Number of Attempts- Per Direct Observation	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.

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States