Ultrasound-Assisted Lumbar Puncture in Children

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099642
• Other study ID #: UALP
• Status: Completed
• Phase: N/A
• Start date: June 10, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: April 2019
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever

Intervention

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.

Locations

Country	Name	City	State
Canada	Sainte-Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in performer	If the lumbar puncture was attempted by a second person following the first attempts	15 minutes
Secondary	Time of procedure	Time to perform the lumbar puncture	30 minutes
Secondary	Complication	Occurence of any complication	30 minutes