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OpenTrials
Completed

NCT Number: NCT03099642

Ultrasound-Assisted Lumbar Puncture in Children

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.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sainte-Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Total lumbar puncture success rate

    Time frame: 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

  2. Change in performer

    Time frame: 15 minutes

    If the lumbar puncture was attempted by a second person following the first attempts

  3. Time of procedure

    Time frame: 30 minutes

    Time to perform the lumbar puncture

  4. Complication

    Time frame: 30 minutes

    Occurence of any complication

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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