N/A
N=128
The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
Traumatic Lumbar Puncture
Bottom Line
View on ClinicalTrials.gov: NCT02133066 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group — 58; 31 percent success
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bedside Ultrasound-Assisted Site Marking (Procedure); Mindray M7 Ultrasound (Device); Routine lumbar puncture (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group |
58; 31 | — |
| SECONDARY Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group |
75; 44 | — |
| SECONDARY Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients |
46; 48.1 | — |
| SECONDARY Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients |
26.8; 25 | — |
Summary
The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.
Eligibility Criteria
Inclusion Criteria
- Less than or equal to six months of age
- Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
- Availability of a study sonographer to perform bedside ultrasound
Exclusion Criteria
- Known spinal cord abnormality (e.g., tethered cord, spina bifida)
Data sourced from ClinicalTrials.gov (NCT02133066). 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.