Infant/ Neonate Lumbar Puncture
Conditions
Keywords
pediatric, lumbar puncture, ultrasonography, efficacy
Brief summary
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients
Detailed description
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture
Interventions
PROCEDUREUltrasound assisted lumbar puncture
An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
* Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study
Exclusion criteria
* previous back surgeries * parent/ guardian inability to understand informed consent * parent/guardian refusal of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Traumatic lumbar puncture | up to 24 hours | RBC\>10,000/ mm3 on spinal fluid analysis |
| Unsuccessful lumbar puncture | average of <1hour | failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | average of <7days | as reported in the subjects' medical record |
Other
| Measure | Time frame | Description |
|---|---|---|
| clinical outcome/ hospital course of the patient | 30days | whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record |
| perception of the clinician on the usefulness of bedside ultrasound if used | up to 24 hours | as rated on a 1-5 Likert scale by the operator on the data collection form |
| number of lumbar puncture attempts | average of <1hour | as recorded on the data collection form |
| time to completion of lumbar puncture | average of <1hour | as reported in the data collection form (measured in seconds) |
Countries
United States
Outcome results
None listed