Ultrasound-Assisted Lumbar Puncture in Children

Not Applicable

Completed

• Conditions: Fever
• Interventions: Radiation: ultrasound-assisted lumbar puncture

• Registration Number: NCT03099642
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-04
• Study Start: 2017-06-10
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound assisted lumbar puncture	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

Primary Outcome Measures

Name	Time	Method
First-tie success	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

Name	Time	Method
Total lumbar puncture success rate	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
Complication	30 minutes	Occurence of any complication
Time of procedure	30 minutes	Time to perform the lumbar puncture
Change in performer	15 minutes	If the lumbar puncture was attempted by a second person following the first attempts

Trial Locations

Locations (1)

Sainte-Justine Hospital; 🇨🇦 Montreal, Quebec, Canada