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

August 1, 2017 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional 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)
Mindray M7 Ultrasound marking
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.
Other Names:
  • 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
Other Names:
  • M7/M7T Diagnostic Ultrasound
Placebo Comparator: Routine lumbar puncture
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
Lumbar puncture will be performed per routine standard of care

What is the study measuring?

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
Time Frame: 30 minutes
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
Time Frame: 30 minutes
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
Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 2 days
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
Time Frame: Participants will be followed until discontinuation of antibiotics, an expected average of 2 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Aaron E Chen, MD, CHOP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-010667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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