Overview

This trial is active, not recruiting.

Condition traumatic lumbar puncture
Treatments bedside ultrasound-assisted site marking, mindray m7 ultrasound, routine lumbar puncture
Sponsor Children's Hospital of Philadelphia
Start date May 2014
End date February 2016
Trial size 128 participants
Trial identifier NCT02133066, 13-010667

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Mindray M7 Ultrasound marking
bedside ultrasound-assisted site marking Mindray M7 Ultrasound
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.
mindray m7 ultrasound M7/M7T Diagnostic Ultrasound
Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
(Placebo Comparator)
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
routine lumbar puncture
Lumbar puncture will be performed per routine standard of care

Primary Outcomes

Measure
Proportion of successful first attempt lumbar punctures in the ultrasound-assisted group as compared to the non-ultrasound assisted group
time frame: 30 minutes

Secondary Outcomes

Measure
Proportion of overall success of lumbar punctures in the ultrasound-assisted group versus the non-ultrasound-assisted group
time frame: 30 minutes
Length of hospitalization in ultrasound-assisted lumbar puncture patients versus non-ultrasound-assisted patients
time frame: 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
time frame: Participants will be followed until discontinuation of antibiotics, an expected average of 2 days

Eligibility Criteria

Male or female participants up to 6 months old.

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)

Additional Information

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
Principal investigator Aaron E Chen, MD
Description The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia, 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.