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OpenTrials
Completed

NCT Number: NCT02949869

Variability of Infant LP Insertion Site Based On Procedural Experience

The reported rate of unsuccessful traditional LP in children (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors affect LP success including provider experience. CSF is obtained by puncturing the subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many have hypothesized that the width of this space may predict success. Anecdotally, trainees and those with less experience, tend to perform the LP too low (caudally), where the subarachnoid space tapers, or too laterally (off the midline) resulting in higher failure rates. The investigators seek to determine if planned LP insertion sites vary between training and attendings, and if so, could the decreased success be explained by smaller subarachnoid spaces.

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Key information

Conditions

Traumatic Lumbar Puncture

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Less than or equal to 12 months of age
  • Availability of a study sonographer to perform bedside ultrasound

Exclusion criteria

  • Prior history of LP in preceding 72 hours
  • Known spinal cord abnormality (i.e., tethered cord, spina bifida)
  • Clinically unstable patients (acuity level 1)

Treatment and study plan

Spinal Sonography

Other

As described previously

Primary outcomes

  1. Proportion of Trainee & Attending LP Insertion Sites that are the same

    Time frame: 18 months

    Plan to visualize marked spaces with US to delineate if the trainee and attending marked the same or different interspace (we will quanity the proportion of same interspaces marked and for those that are different, we will quantify the proportion above or below the attending marking)

Secondary outcomes

  1. Subarachnoid Space Width

    Time frame: 18 months

    Measure subarachnoid space width (mm)

  2. Subarachnoid Space Area

    Time frame: 18 months

    Measure subarachnoid space area (mm2)

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2016
Registry last updated
Nov 1, 2018

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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