N/A
N=81
Ultrasound vs Palpation for Infant Lumbar Puncture
Spinal; Puncture, Complications
Bottom Line
View on ClinicalTrials.gov: NCT02373774 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts — 18; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts |
18; 19 | — |
| SECONDARY Number of Attempts- Per Direct Observation |
2; 2 | — |
Summary
The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.
Eligibility Criteria
Inclusion Criteria
- Patient is less than 90 days old.
- Patient is receiving a lumbar puncture
Exclusion Criteria
- Patient is clinically unstable
- Patient had a previous lumbar puncture in the past 24 hours
- An outside consultant (not working in ED) is performing the LP
- Patient has developmental delay or neurological impairment
- There is no legal guardian present
- The legal guardians speak neither English nor Spanish
- There is no ultrasound personnel available to enroll
Data sourced from ClinicalTrials.gov (NCT02373774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.