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Clinical Trials/NCT03099642
NCT03099642
Completed
Not Applicable

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

St. Justine's Hospital1 site in 1 country166 target enrollmentJune 10, 2017
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ConditionsFever

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fever
Sponsor
St. Justine's Hospital
Enrollment
166
Locations
1
Primary Endpoint
First-tie success
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2017
End Date
October 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jocelyn Gravel

MD, MSc

St. Justine's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

First-tie success

Time Frame: 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 Outcomes

  • Total lumbar puncture success rate(15 minutes)
  • Complication(30 minutes)
  • Time of procedure(30 minutes)
  • Change in performer(15 minutes)

Study Sites (1)

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