Clinical trial NCT02133066: The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
Official title: The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Lumbar Punctures in a Pediatric Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Lumbar Puncture
Keywords: Ultrasound
Lumbar Puncture
Spinal Tap
Pediatric
Infant
Bedside Ultrasonography
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 128
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of \~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful 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)

Primary outcomes:
measure: Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
timeFrame: 30 minutes
Secondary outcomes:
measure: Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group
timeFrame: 30 minutes
measure: Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 2 days
measure: Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
timeFrame: Participants will be followed until discontinuation of antibiotics, an expected average of 2 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia Emergency Department
state: Pennsylvania
Study officials:
affiliation: CHOP
name: Aaron E Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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