Variability of Infant LP Insertion Site Based On Procedural Experience

NCT ID: NCT02949869

Last Updated: 2018-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Traumatic Lumbar Puncture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Infant Lumbar Punctures

Infants will all be assigned to received two sets of skin markings and sonography exam to assess lumbar puncture landmarks and anatomy.

Group Type EXPERIMENTAL

Spinal Sonography

Intervention Type OTHER

As described previously

Interventions

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Spinal Sonography

As described previously

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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)
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Vieira

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Vieira, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Schreiner RL, Kleiman MB. Incidence and effect of traumatic lumbar puncture in the neonate. Dev Med Child Neurol. 1979 Aug;21(4):483-7. doi: 10.1111/j.1469-8749.1979.tb01652.x.

Reference Type BACKGROUND
PMID: 520695 (View on PubMed)

Pinheiro JM, Furdon S, Ochoa LF. Role of local anesthesia during lumbar puncture in neonates. Pediatrics. 1993 Feb;91(2):379-82.

Reference Type BACKGROUND
PMID: 8424014 (View on PubMed)

Other Identifiers

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IRB-P00023833

Identifier Type: -

Identifier Source: org_study_id

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