The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Lumbar Punctures in a Pediatric Emergency Department: A Randomized Controlled Trial

Conditions
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Traumatic Lumbar Puncture

Intervention / Treatment
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* Procedure: Bedside Ultrasound-Assisted Site Marking
* Device: Mindray M7 Ultrasound
* Procedure: Routine lumbar puncture


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: US-Assisted site marking for Lumbar Punctures (LP)<br>Mindray M7 Ultrasound marking | Procedure: Bedside Ultrasound-Assisted Site Marking<br>* Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.<br>* Other names: Mindray M7 Ultrasound;Device: Mindray M7 Ultrasound<br>* Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap<br>* Other names: M7/M7T Diagnostic Ultrasound;|
| Placebo Comparator: Routine lumbar puncture<br>These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a standard-of-care spinal tap performed by the clinician | Procedure: Routine lumbar puncture<br>* Lumbar puncture will be performed per routine standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group | First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group | Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group | 30 minutes | 
| Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization. | Participants will be followed for the duration of the hospital stay, an expected average of 2 days | 
| Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients | If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics. | Participants will be followed until discontinuation of antibiotics, an expected average of 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Lumbar Puncture, Spinal Tap, Pediatric, Infant, Bedside Ultrasonography