Ultrasound-Assisted Lumbar Puncture in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Radiation: ultrasound-assisted lumbar puncture

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • Sainte-Justine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 minutes
Change in performer	If the lumbar puncture was attempted by a second person following the first attempts	15 minutes
Time of procedure	Time to perform the lumbar puncture	30 minutes
Complication	Occurence of any complication	30 minutes

Collaborators and Investigators

• Sponsor: St. Justine's Hospital
• Investigators: Principal Investigator: Jocelyn Gravel, MD, MSc, Sainte-Justine Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: children; Point of care ultrasound; lumbar puncture
• Other Study ID Numbers: UALP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No