Bedside Ultrasound Assisted Pediatric Lumbar Puncture
Primary Purpose
Infant/ Neonate Lumbar Puncture
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound assisted lumbar puncture
Sponsored by
About this trial
This is an interventional supportive care trial for Infant/ Neonate Lumbar Puncture focused on measuring pediatric, lumbar puncture, ultrasonography, efficacy
Eligibility Criteria
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.
Sites / Locations
- Advocate Christ Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
90 days and under--Interventional
90 days and under--control
Over 90 days--Interventional
Over 90 days--Control
Arm Description
Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach
Outcomes
Primary Outcome Measures
Traumatic lumbar puncture
RBC>10,000/ mm3 on spinal fluid analysis
Unsuccessful lumbar puncture
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
Secondary Outcome Measures
Hospital length of stay
as reported in the subjects' medical record
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02193763
Brief Title
Bedside Ultrasound Assisted Pediatric Lumbar Puncture
Official Title
Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Suspended
Why Stopped
PI has relocated to another institution, no other site PI to take over
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients
Detailed Description
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant/ Neonate Lumbar Puncture
Keywords
pediatric, lumbar puncture, ultrasonography, efficacy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
90 days and under--Interventional
Arm Type
Experimental
Arm Description
Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
Arm Title
90 days and under--control
Arm Type
No Intervention
Arm Description
Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
Arm Title
Over 90 days--Interventional
Arm Type
Experimental
Arm Description
Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
Arm Title
Over 90 days--Control
Arm Type
No Intervention
Arm Description
Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach
Intervention Type
Procedure
Intervention Name(s)
Ultrasound assisted lumbar puncture
Other Intervention Name(s)
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,
Intervention Description
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.
Primary Outcome Measure Information:
Title
Traumatic lumbar puncture
Description
RBC>10,000/ mm3 on spinal fluid analysis
Time Frame
up to 24 hours
Title
Unsuccessful lumbar puncture
Description
failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
Time Frame
average of <1hour
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
as reported in the subjects' medical record
Time Frame
average of <7days
Other Pre-specified Outcome Measures:
Title
clinical outcome/ hospital course of the patient
Description
whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record
Time Frame
30days
Title
number of lumbar puncture attempts
Description
as recorded on the data collection form
Time Frame
average of <1hour
Title
time to completion of lumbar puncture
Description
as reported in the data collection form (measured in seconds)
Time Frame
average of <1hour
Title
perception of the clinician on the usefulness of bedside ultrasound if used
Description
as rated on a 1-5 Likert scale by the operator on the data collection form
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Lam, MD
Organizational Affiliation
Advocate Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bedside Ultrasound Assisted Pediatric Lumbar Puncture
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