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CompletedNCT03099642Updated Apr 4, 2019

Ultrasound-Assisted Lumbar Puncture in Children

An interventional study of ultrasound-assisted lumbar puncture in Fever, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fever

Keywords

  • lumbar puncture
  • Point of care ultrasound
  • children
03

In context

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • 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

  • No intervention
    Standard lumbar puncture

    The control group will have a standard landmark-based lumbar puncture

Interventions

  • Radiationultrasound-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.

06

What researchers measure

Primary outcomes

  1. First-tie success

    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.

    Time frame: 15 minutes

Secondary outcomes

  1. Total lumbar puncture success rate

    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

    Time frame: 15 minutes

  2. Change in performer

    If the lumbar puncture was attempted by a second person following the first attempts

    Time frame: 15 minutes

  3. Time of procedure

    Time to perform the lumbar puncture

    Time frame: 30 minutes

  4. Complication

    Occurence of any complication

    Time frame: 30 minutes

07

Study locations

1 site
  • Sainte-Justine Hospital
    Montreal, Quebec H3T1C5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03099642
Lead sponsor
St. Justine's Hospital
Responsible party
Jocelyn Gravel (MD, MSc, St. Justine's Hospital) — Principal investigator
First posted
Apr 4, 2017
Start date
Jun 10, 2017
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Apr 4, 2019

Study contacts

Jocelyn Gravel, MD, MSc
principal investigator · Sainte-Justine Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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