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Ultrasound-Assisted Lumbar Puncture in Children

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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

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.

Condition or disease Intervention/treatment Phase
Fever Radiation: ultrasound-assisted lumbar puncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Emergency Physician Performed Ultrasound-Assisted Lumbar Puncture in a Pediatric Population: A Randomized Controlled Trial
Actual Study Start Date : June 10, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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
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.

No Intervention: Standard lumbar puncture
The control group will have a standard landmark-based lumbar puncture



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Change in performer [ Time Frame: 15 minutes ]
    If the lumbar puncture was attempted by a second person following the first attempts

  3. Time of procedure [ Time Frame: 30 minutes ]
    Time to perform the lumbar puncture

  4. Complication [ Time Frame: 30 minutes ]
    Occurence of any complication



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03099642


Locations
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Canada, Quebec
Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Principal Investigator: Jocelyn Gravel, MD, MSc Sainte-Justine Hospital

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Responsible Party: Jocelyn Gravel, MD, MSc, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03099642     History of Changes
Other Study ID Numbers: UALP
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jocelyn Gravel, St. Justine's Hospital:
lumbar puncture
Point of care ultrasound
children