Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-05 @ 8:49 PM
Study NCT ID:
NCT02133066
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2014-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: