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
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
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
NCT ID
NCT02133066
First Posted
May 2, 2014
Last Updated
August 1, 2017
Sponsor
Children's Hospital of Philadelphia
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
Abo A, Chen L, Johnston P, Santucci K. Positioning for lumbar puncture in children evaluated by bedside ultrasound. Pediatrics. 2010 May;125(5):e1149-53. doi: 10.1542/peds.2009-0646. Epub 2010 Apr 19.
Results Reference
background
PubMed Identifier
16510670
Citation
Baxter AL, Fisher RG, Burke BL, Goldblatt SS, Isaacman DJ, Lawson ML. Local anesthetic and stylet styles: factors associated with resident lumbar puncture success. Pediatrics. 2006 Mar;117(3):876-81. doi: 10.1542/peds.2005-0519. Erratum In: Pediatrics. 2006 May;117(5):1870.
Results Reference
background
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
background
PubMed Identifier
11692234
Citation
Coley BD, Murakami JW, Koch BL, Shiels WE 2nd, Bates G, Hogan M. Diagnostic and interventional ultrasound of the pediatric spine. Pediatr Radiol. 2001 Nov;31(11):775-85. doi: 10.1007/s002470100535.
Results Reference
background
PubMed Identifier
18810417
Citation
Dietrich AM, Coley BD. Bedside pediatric emergency evaluation through ultrasonography. Pediatr Radiol. 2008 Nov;38 Suppl 4:S679-84. doi: 10.1007/s00247-008-0890-1. Epub 2008 Sep 23.
Results Reference
background
PubMed Identifier
17349903
Citation
Ferre RM, Sweeney TW. Emergency physicians can easily obtain ultrasound images of anatomical landmarks relevant to lumbar puncture. Am J Emerg Med. 2007 Mar;25(3):291-6. doi: 10.1016/j.ajem.2006.08.013.
Results Reference
background
PubMed Identifier
11892638
Citation
Furness G, Reilly MP, Kuchi S. An evaluation of ultrasound imaging for identification of lumbar intervertebral level. Anaesthesia. 2002 Mar;57(3):277-80. doi: 10.1046/j.1365-2044.2002.2403_4.x.
Results Reference
background
PubMed Identifier
14984904
Citation
Lam WW, Ai V, Wong V, Lui WM, Chan FL, Leong L. Ultrasound measurement of lumbosacral spine in children. Pediatr Neurol. 2004 Feb;30(2):115-21. doi: 10.1016/j.pediatrneurol.2003.07.002.
Results Reference
background
PubMed Identifier
17321005
Citation
Nigrovic LE, Kuppermann N, Neuman MI. Risk factors for traumatic or unsuccessful lumbar punctures in children. Ann Emerg Med. 2007 Jun;49(6):762-71. doi: 10.1016/j.annemergmed.2006.10.018. Epub 2007 Feb 23.
Results Reference
background
PubMed Identifier
21492866
Citation
Nigrovic LE, Shah SS, Neuman MI. Correction of cerebrospinal fluid protein for the presence of red blood cells in children with a traumatic lumbar puncture. J Pediatr. 2011 Jul;159(1):158-9. doi: 10.1016/j.jpeds.2011.02.038. Epub 2011 Apr 14.
Results Reference
background
PubMed Identifier
17901137
Citation
Nomura JT, Leech SJ, Shenbagamurthi S, Sierzenski PR, O'Connor RE, Bollinger M, Humphrey M, Gukhool JA. A randomized controlled trial of ultrasound-assisted lumbar puncture. J Ultrasound Med. 2007 Oct;26(10):1341-8. doi: 10.7863/jum.2007.26.10.1341.
Results Reference
background
PubMed Identifier
22684159
Citation
Oncel S, Gunlemez A, Anik Y, Alvur M. Positioning of infants in the neonatal intensive care unit for lumbar puncture as determined by bedside ultrasonography. Arch Dis Child Fetal Neonatal Ed. 2013 Mar;98(2):F133-5. doi: 10.1136/archdischild-2011-301475. Epub 2012 Jun 9.
Results Reference
background
PubMed Identifier
20577138
Citation
Pappano D. "Traumatic tap" proportion in pediatric lumbar puncture. Pediatr Emerg Care. 2010 Jul;26(7):487-9. doi: 10.1097/PEC.0b013e3181e5bedd.
Results Reference
background
PubMed Identifier
15707816
Citation
Peterson MA, Abele J. Bedside ultrasound for difficult lumbar puncture. J Emerg Med. 2005 Feb;28(2):197-200. doi: 10.1016/j.jemermed.2004.09.008.
Results Reference
background
PubMed Identifier
8424014
Citation
Pinheiro JM, Furdon S, Ochoa LF. Role of local anesthesia during lumbar puncture in neonates. Pediatrics. 1993 Feb;91(2):379-82.
Results Reference
background
PubMed Identifier
520695
Citation
Schreiner RL, Kleiman MB. Incidence and effect of traumatic lumbar puncture in the neonate. Dev Med Child Neurol. 1979 Aug;21(4):483-7. doi: 10.1111/j.1469-8749.1979.tb01652.x.
Results Reference
background
PubMed Identifier
23624433
Citation
Srinivasan L, Shah SS, Abbasi S, Padula MA, Harris MC. Traumatic lumbar punctures in infants hospitalized in the neonatal intensive care unit. Pediatr Infect Dis J. 2013 Oct;32(10):1150-2. doi: 10.1097/INF.0b013e31829862b7.
Results Reference
background
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The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
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