Ultrasound-Assisted Lumbar Puncture in Children

NCT03099642 | Completed

• 1 other identifier: UALP
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever

Keywords

lumbar puncture; Point of care ultrasound; children

Outcome Measures

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.

  15 minutes

Secondary Outcomes (4)

• Total lumbar puncture success rate

  15 minutes

• Change in performer

  15 minutes

• Time of procedure

  30 minutes

• Complication

  30 minutes

Study Arms (2)

Ultrasound assisted lumbar puncture

EXPERIMENTAL

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

Standard lumbar puncture

NO INTERVENTION

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

Interventions

ultrasound-assisted lumbar puncture RADIATION

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.

Ultrasound assisted lumbar puncture

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Sainte-Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jocelyn Gravel, MD, MSc

  Sainte-Justine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: June 10, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)