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Ultrasound vs Palpation for Infant Lumbar Puncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373774
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
David Kessler, 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.

Condition or disease Intervention/treatment Phase
Spinal; Puncture, Complications Device: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: (Zonare Z1.pro and/or Sonosite Mturbo)




Primary Outcome Measures :
  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 Outcome Measures :
  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.

  2. Traumatic Lumbar Puncture- per lab results [ Time Frame: Outcome measured on the same day of the procedure ]
    Defined as cerebrospinal fluid with greater than 1000 red blood cells per highpowered field. (will look for first attempt and for overall)

  3. Initial Lumbar Interspace Selection- as measured during clip review [ Time Frame: Clip review for outcome will occur on average within one month of the procedure ]
    Defined as the lumbar interspace that the clinician performing the lumbar puncture initially inserts the lumbar puncture needle into, with the level determined by the post-procedural ultrasound by a blinded sonologist.

  4. Highest Lumbar Interspace Selectionas-measured during clip review [ Time Frame: Clip review for outcome occurs on average within one month of the procedure ]
    Defined as the lumbar interspace that the lumbar puncture needle is inserted that is the most caudal (when more than one is performed), with level determined by the post-procedural ultrasound by a blinded sonologist.

  5. Lumbar Puncture Success - as per lab results ( <1000 red blood cells per high powered field on any attempt) [ Time Frame: Outcome measured on the same day of the procedure ]
    Overall success will be defined as obtaining fluid with csf <1000 rbcs by any practitioner on any attempt



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373774


Locations
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United States, New York
Columbia University
NY, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: David O Kessler, MD, MSc Columbia University
Principal Investigator: Gerald Behr, MD Columbia University
Principal Investigator: Peter S Dayan, MD, MSc Columbia University
Publications:

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Responsible Party: David Kessler, Assistant Professor, Columbia University
ClinicalTrials.gov Identifier: NCT02373774    
Other Study ID Numbers: AAAO3705
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Keywords provided by David Kessler, Columbia University:
infant
lumbar puncture
patient safety
ultrasound
Additional relevant MeSH terms:
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Wounds and Injuries