Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound-Assisted Lumbar Puncture in Children

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: NCT03099642
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE June 10, 2017
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
First-tie success [ Time Frame: 15 minutes ]
First-time lumbar puncture success rate is defined by the presence of at least 0.5 mL of cerebrospinal fluid with red blood cell count < 1,000/mm3.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • Total lumbar puncture success rate [ Time Frame: 15 minutes ]
    defined by the presence of at least 0.5 mL of cerebrospinal fluid with red blood cell count < 1,000/mm3 in any number of attempt
  • Change in performer [ Time Frame: 15 minutes ]
    If the lumbar puncture was attempted by a second person following the first attempts
  • Time of procedure [ Time Frame: 30 minutes ]
    Time to perform the lumbar puncture
  • Complication [ Time Frame: 30 minutes ]
    Occurence of any complication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound-Assisted Lumbar Puncture in Children
Official Title  ICMJE Emergency Physician Performed Ultrasound-Assisted Lumbar Puncture in a Pediatric Population: A Randomized Controlled Trial
Brief Summary The aim of this study is to determine if emergency physician performed ultrasound-assisted lumbar puncture improves first-time success rates in a pediatric population. This will be done by comparison with current landmark-based approach to the procedure.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Fever
Intervention  ICMJE Radiation: ultrasound-assisted lumbar puncture
The ultrasound probe type will be selected by the treating pediatric emergency physician who has been trained according to standards outlined below. They will first identify the conus medullaris and make a horizontal marking with a sterile pen on the patient's back. Using a transverse view, they will then identify the midline of the patient's spine (using adjacent spinous processes) and will make 2 vertical skin markings on either side of the probe. Next, they will orient the probe in a longitudinal view to identify the desired vertebral interspace and will make 2 horizontal skin markings on either side of the probe at this level. Finally the 4 lines will be joined together at an intersection point, which will be the predetermined site for puncture attempt.
Study Arms  ICMJE
  • Experimental: Ultrasound assisted lumbar puncture
    The intervention of interest will be the ultrasound-assisted lumbar puncture (UALP). To do this, the treating physician will perform a bedside ultrasound of the spine to identify and mark the level of the conus medullaris and preferred puncture site prior to LP
    Intervention: Radiation: ultrasound-assisted lumbar puncture
  • No Intervention: Standard lumbar puncture
    The control group will have a standard landmark-based lumbar puncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
166
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
162
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient less than 19 years of age
  • Requiring a lumbar puncture as part of their work-up, as determined by the treating pediatric emergency physician.

Exclusion Criteria:

  • • Patients with known spine or spinal cord abnormalities

    • Patients with ventricular shunts
    • Patients deemed too unstable to have procedure performed
    • Patients at risk for significant bleeding (coagulopathy, thrombocytopenia, etc)
    • Parents unable to give consent or patients unable to assent for an acute reason
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099642
Other Study ID Numbers  ICMJE UALP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jocelyn Gravel, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jocelyn Gravel, MD, MSc Sainte-Justine Hospital
PRS Account St. Justine's Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP