Ultrasound vs Palpation for Infant Lumbar Puncture

NCT02373774 | Completed Results DMC

• 1 other identifier: AAAO3705
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.

Conditions

Spinal; Puncture, Complications

Keywords

infant; lumbar puncture; patient safety; ultrasound

Outcome Measures

Primary Outcomes (1)

• Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts

  Our primary outcome of the clinical trial is binary, success or failure of lumbar puncture. Success is defined as obtaining a sample of cerebrospinal fluid on the first attempt that has a red blood cell count of \<1000 red blood cells per high-powered field.

  Outcome measured on the same day of the procedure

Secondary Outcomes (1)

• Number of Attempts- Per Direct Observation

  Outcome measured at the time of the procedure (same day)

Study Arms (2)

Standard Anatomic Palpation Technique

NO INTERVENTION

Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace to perform lumbar puncture.

Pre-Procedural Ultrasound

EXPERIMENTAL

Participants randomized to this group will receive an ultrasound of the interspace selected via the palpation method prior to performance of the lumbar puncture to determine measurements of appropriate angle and depth and evaluation of any overlying vasculature.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.

Also known as: (Zonare Z1.pro and/or Sonosite Mturbo)

Pre-Procedural Ultrasound

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient is less than 90 days old.
• Patient is receiving a lumbar puncture

You may not qualify if:

• Patient is clinically unstable
• Patient had a previous lumbar puncture in the past 24 hours
• An outside consultant (not working in ED) is performing the LP
• Patient has developmental delay or neurological impairment
• There is no legal guardian present
• The legal guardians speak neither English nor Spanish
• There is no ultrasound personnel available to enroll

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (23)

• Alpern ER, Stanley RM, Gorelick MH, Donaldson A, Knight S, Teach SJ, Singh T, Mahajan P, Goepp JG, Kuppermann N, Dean JM, Chamberlain JM; Pediatric Emergency Care Applied Research Network. Epidemiology of a pediatric emergency medicine research network: the PECARN Core Data Project. Pediatr Emerg Care. 2006 Oct;22(10):689-99. doi: 10.1097/01.pec.0000236830.39194.c0.

  PMID: 17047467 BACKGROUND

• Jain S, Cheng J, Alpern ER, Thurm C, Schroeder L, Black K, Ellison AM, Stone K, Alessandrini EA. Management of febrile neonates in US pediatric emergency departments. Pediatrics. 2014 Feb;133(2):187-95. doi: 10.1542/peds.2013-1820. Epub 2014 Jan 27.

  PMID: 24470644 BACKGROUND

• Kessler DO, Arteaga G, Ching K, Haubner L, Kamdar G, Krantz A, Lindower J, Miller M, Petrescu M, Pusic MV, Rocker J, Shah N, Strother C, Tilt L, Weinberg ER, Chang TP, Fein DM, Auerbach M. Interns' success with clinical procedures in infants after simulation training. Pediatrics. 2013 Mar;131(3):e811-20. doi: 10.1542/peds.2012-0607. Epub 2013 Feb 25.

  PMID: 23439901 BACKGROUND

• 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.

  PMID: 17321005 BACKGROUND

• Glatstein MM, Zucker-Toledano M, Arik A, Scolnik D, Oren A, Reif S. Incidence of traumatic lumbar puncture: experience of a large, tertiary care pediatric hospital. Clin Pediatr (Phila). 2011 Nov;50(11):1005-9. doi: 10.1177/0009922811410309. Epub 2011 May 27.

  PMID: 21622691 BACKGROUND

• Bonadio W. Pediatric lumbar puncture and cerebrospinal fluid analysis. J Emerg Med. 2014 Jan;46(1):141-50. doi: 10.1016/j.jemermed.2013.08.056. Epub 2013 Nov 1.

  PMID: 24188604 BACKGROUND

• Duniec L, Nowakowski P, Kosson D, Lazowski T. Anatomical landmarks based assessment of intravertebral space level for lumbar puncture is misleading in more than 30%. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):1-6. doi: 10.5603/AIT.2013.0001.

  PMID: 23572300 BACKGROUND

• 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.

  PMID: 11892638 BACKGROUND

• Shekelle PG, Wachter RM, Pronovost PJ, Schoelles K, McDonald KM, Dy SM, Shojania K, Reston J, Berger Z, Johnsen B, Larkin JW, Lucas S, Martinez K, Motala A, Newberry SJ, Noble M, Pfoh E, Ranji SR, Rennke S, Schmidt E, Shanman R, Sullivan N, Sun F, Tipton K, Treadwell JR, Tsou A, Vaiana ME, Weaver SJ, Wilson R, Winters BD. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evid Rep Technol Assess (Full Rep). 2013 Mar;(211):1-945.

  PMID: 24423049 BACKGROUND

• Coley BD, Shiels WE 2nd, Hogan MJ. Diagnostic and interventional ultrasonography in neonatal and infant lumbar puncture. Pediatr Radiol. 2001 Jun;31(6):399-402. doi: 10.1007/s002470100453.

  PMID: 11436885 BACKGROUND

• 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.

  PMID: 20403933 BACKGROUND

• Lo MD, Parisi MT, Brown JC, Klein EJ. Sitting or tilt position for infant lumbar puncture does not increase ultrasound measurements of lumbar subarachnoid space width. Pediatr Emerg Care. 2013 May;29(5):588-91. doi: 10.1097/PEC.0b013e31828e630d.

  PMID: 23603648 BACKGROUND

• 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.

  PMID: 22684159 BACKGROUND

• Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.

  PMID: 23532866 BACKGROUND

• 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.

  PMID: 21444601 BACKGROUND

• Bailie HC, Arthurs OJ, Murray MJ, Kelsall AW. Weight-based determination of spinal canal depth for paediatric lumbar punctures. Arch Dis Child. 2013 Nov;98(11):877-80. doi: 10.1136/archdischild-2013-303793. Epub 2013 Aug 21.

  PMID: 23966025 BACKGROUND

• Wilson DA, Prince JR. John Caffey award. MR imaging determination of the location of the normal conus medullaris throughout childhood. AJR Am J Roentgenol. 1989 May;152(5):1029-32. doi: 10.2214/ajr.152.5.1029.

  PMID: 2650477 BACKGROUND

• Hill CA, Gibson PJ. Ultrasound determination of the normal location of the conus medullaris in neonates. AJNR Am J Neuroradiol. 1995 Mar;16(3):469-72.

  PMID: 7793365 BACKGROUND

• Wolf S, Schneble F, Troger J. The conus medullaris: time of ascendence to normal level. Pediatr Radiol. 1992;22(8):590-2. doi: 10.1007/BF02015359.

  PMID: 1491937 BACKGROUND

• Sahin F, Selcuki M, Ecin N, Zenciroglu A, Unlu A, Yilmaz F, Mavis N, Saribas S. Level of conus medullaris in term and preterm neonates. Arch Dis Child Fetal Neonatal Ed. 1997 Jul;77(1):F67-9. doi: 10.1136/fn.77.1.f67.

  PMID: 9279188 BACKGROUND

• Rozzelle CJ, Reed GT, Kirkman JL, Shannon CN, Chern JJ, Wellons JC 3rd, Tubbs RS. Sonographic determination of normal Conus Medullaris level and ascent in early infancy. Childs Nerv Syst. 2014 Apr;30(4):655-8. doi: 10.1007/s00381-013-2310-6. Epub 2013 Nov 1.

  PMID: 24178234 BACKGROUND

• Tame SJ, Burstal R. Investigation of the radiological relationship between iliac crests, conus medullaris and vertebral level in children. Paediatr Anaesth. 2003 Oct;13(8):676-80. doi: 10.1046/j.1460-9592.2003.01120.x.

  PMID: 14535904 BACKGROUND

• Kesler H, Dias MS, Kalapos P. Termination of the normal conus medullaris in children: a whole-spine magnetic resonance imaging study. Neurosurg Focus. 2007;23(2):E7. doi: 10.3171/FOC-07/08/E7.

  PMID: 17961006 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Raquel Schrager
• Organization: Columbia University Medical Center

rs3823@cumc.columbia.edu

(212) 305-4687

Study Officials

• David O Kessler, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

• Gerald Behr, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Peter S Dayan, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: February 27, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 24, 2023
• Results First Posted: October 24, 2023

Record last verified: 2023-10

Locations

US (1)