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

Primary Purpose

Traumatic Lumbar Puncture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bedside Ultrasound-Assisted Site Marking
Mindray M7 Ultrasound
Routine lumbar puncture
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Traumatic Lumbar Puncture focused on measuring Ultrasound, Lumbar Puncture, Spinal Tap, Pediatric, Infant, Bedside Ultrasonography

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Children's Hospital of Philadelphia Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

US-Assisted site marking for Lumbar Punctures (LP)

Routine lumbar puncture

Arm Description

Mindray M7 Ultrasound marking

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
May 2, 2014
Last Updated
August 1, 2017
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02133066
Brief Title
The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Lumbar Puncture
Keywords
Ultrasound, Lumbar Puncture, Spinal Tap, Pediatric, Infant, Bedside Ultrasonography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US-Assisted site marking for Lumbar Punctures (LP)
Arm Type
Active Comparator
Arm Description
Mindray M7 Ultrasound marking
Arm Title
Routine lumbar puncture
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Bedside Ultrasound-Assisted Site Marking
Other Intervention Name(s)
Mindray M7 Ultrasound
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mindray M7 Ultrasound
Other Intervention Name(s)
M7/M7T Diagnostic Ultrasound
Intervention Description
Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
Intervention Type
Procedure
Intervention Name(s)
Routine lumbar puncture
Intervention Description
Lumbar puncture will be performed per routine standard of care
Primary Outcome Measure Information:
Title
Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
Description
First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group
Description
Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group
Time Frame
30 minutes
Title
Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
Description
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.
Time Frame
Participants will be followed for the duration of the hospital stay, an expected average of 2 days
Title
Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
Description
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.
Time Frame
Participants will be followed until discontinuation of antibiotics, an expected average of 2 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron E Chen, MD
Organizational Affiliation
CHOP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia Emergency Department
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20403933
Citation
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Results Reference
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Results Reference
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PubMed Identifier
21444601
Citation
Bruccoleri RE, Chen L. Needle-entry angle for lumbar puncture in children as determined by using ultrasonography. Pediatrics. 2011 Apr;127(4):e921-6. doi: 10.1542/peds.2010-2511. Epub 2011 Mar 28.
Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps

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