Bedside Ultrasound Assisted Pediatric Lumbar Puncture

Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial

This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients

Study Overview

• Status: Suspended
• Conditions: Infant/ Neonate Lumbar Puncture
• Intervention / Treatment: Procedure: Ultrasound assisted lumbar puncture

Detailed Description

Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study

Exclusion Criteria:

• previous back surgeries
• parent/ guardian inability to understand informed consent
• parent/guardian refusal of informed consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 90 days and under--Interventional; Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture	Procedure: Ultrasound assisted lumbar puncture; An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.; Other Names: Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer; or; Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
No Intervention: 90 days and under--control; Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
Experimental: Over 90 days--Interventional; Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture	Procedure: Ultrasound assisted lumbar puncture; An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.; Other Names: Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer; or; Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
No Intervention: Over 90 days--Control; Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traumatic lumbar puncture	RBC>10,000/ mm3 on spinal fluid analysis	up to 24 hours
Unsuccessful lumbar puncture	failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet	average of <1hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	as reported in the subjects' medical record	average of <7days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome/ hospital course of the patient	whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record	30days
number of lumbar puncture attempts	as recorded on the data collection form	average of <1hour
time to completion of lumbar puncture	as reported in the data collection form (measured in seconds)	average of <1hour
perception of the clinician on the usefulness of bedside ultrasound if used	as rated on a 1-5 Likert scale by the operator on the data collection form	up to 24 hours

Collaborators and Investigators

• Sponsor: Advocate Health Care
• Investigators: Principal Investigator: Samuel Lam, MD, Advocate Health Care

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 13, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: pediatric; efficacy; ultrasonography; lumbar puncture
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: AHC 4746