The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps
NCT ID: NCT02133066
Last Updated: 2017-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2014-05-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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US-Assisted site marking for Lumbar Punctures (LP)
Mindray M7 Ultrasound marking
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.
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
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
Routine lumbar puncture
Lumbar puncture will be performed per routine standard of care
Interventions
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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.
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
Routine lumbar puncture
Lumbar puncture will be performed per routine standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
* Availability of a study sonographer to perform bedside ultrasound
Exclusion Criteria
6 Months
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Aaron E Chen, MD
Role: PRINCIPAL_INVESTIGATOR
CHOP
Locations
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Children's Hospital of Philadelphia Emergency Department
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pappano D. "Traumatic tap" proportion in pediatric lumbar puncture. Pediatr Emerg Care. 2010 Jul;26(7):487-9. doi: 10.1097/PEC.0b013e3181e5bedd.
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.
Pinheiro JM, Furdon S, Ochoa LF. Role of local anesthesia during lumbar puncture in neonates. Pediatrics. 1993 Feb;91(2):379-82.
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.
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.
Other Identifiers
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13-010667
Identifier Type: -
Identifier Source: org_study_id
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