Variability of Infant LP Insertion Site Based On Procedural Experience

Not Applicable

Completed

• Conditions: Traumatic Lumbar Puncture
• Interventions: Other: Spinal Sonography

• Registration Number: NCT02949869
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Study Start: 2016-11
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infant Lumbar Punctures	Spinal Sonography	Infants will all be assigned to received two sets of skin markings and sonography exam to assess lumbar puncture landmarks and anatomy.

Primary Outcome Measures

Name	Time	Method
Proportion of Trainee & Attending LP Insertion Sites that are the same	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 Outcome Measures

Name	Time	Method
Subarachnoid Space Area	18 months	Measure subarachnoid space area (mm2)
Subarachnoid Space Width	18 months	Measure subarachnoid space width (mm)

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States