NCT02133066

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Traumatic Lumbar Puncture

Interventions

Type	Name	Description
PROCEDURE	Bedside Ultrasound-Assisted Site Marking	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.
DEVICE	Mindray M7 Ultrasound	Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
PROCEDURE	Routine lumbar puncture	Lumbar puncture will be performed per routine standard of care

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-02-01
• Completion: 2017-01-01
• First posted: 2014-05-07
• Last updated: 2017-08-31
• Results posted: 2017-08-31

Locations

1 site across 1 country: United States