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Ultrasound-Assisted Lumbar Puncture in Children

Emergency Physician Performed Ultrasound-Assisted Lumbar Puncture in a Pediatric Population: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03099642
Enrollment
166
Registered
2017-04-04
Start date
2017-06-10
Completion date
2018-10-31
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever

Keywords

lumbar puncture, Point of care ultrasound, children

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.

Interventions

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.

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
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

* • 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

Design outcomes

Primary

MeasureTime frameDescription
First-tie success15 minutesFirst-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

MeasureTime frameDescription
Total lumbar puncture success rate15 minutesdefined 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 performer15 minutesIf the lumbar puncture was attempted by a second person following the first attempts
Time of procedure30 minutesTime to perform the lumbar puncture
Complication30 minutesOccurence of any complication

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026