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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.
The investigators are conducting a single-center, prospective two-arm parallel group randomized clinical trial in an urban pediatric emergency department to determine if performing an ultrasound prior to lumbar puncture procedure improves success of the procedure.
Patients will be block-randomized into two groups to receive procedural interspace selection via 1) standard anatomic palpation technique or 2) visualization with pre-procedural ultrasound (experimental group).
Standard Anatomic Palpation Technique:
Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace. As variations on the palpation technique exist, the investigators will provide a standardized educational cognitive aid that clinicians can use for this approach.
Pre-Procedural Ultrasound:
Clinicians will first use the standard palpation technique to select an interspace for ultrasound evaluation. A select group of pediatric emergency medicine attendings and fellows who have already trained to a mastery standard with the ultrasound protocol will then conduct the pre-procedural ultrasound. The clinicians performing the lumbar puncture will be provided the following information to conduct the lumbar puncture:
i. Assessment for fluid at the level selected (and the number of interspaces above that have fluid without conus present)
ii. Measurements of appropriate angle and depth
iii. Evaluation of any overlying vasculature
Post-Lumbar Puncture:
After the lumbar puncture, infants randomized to both groups will receive a post-procedural ultrasound scan performed by one of the mastery trained ultrasound physicians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts- Per Direct Observation | Defined as the number of times a lumbar puncture needle is removed from skin and reinserted or a new needle is inserted. | Outcome measured at the time of the procedure (same day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17047467 | Background | 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. | |
| 24470644 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Anatomic Palpation Technique | 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. |
| FG001 | Pre-Procedural Ultrasound | 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. Ultrasound: Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Anatomic Palpation Technique | 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. |
| BG001 | Pre-Procedural Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Outcome measured on the same day of the procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Anatomic Palpation Technique | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raquel Schrager | Columbia University Medical Center | (212) 305-4687 | rs3823@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
| 23439901 | 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. |
| 17321005 | 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. |
| 21622691 | 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. |
| 24188604 | 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. |
| 23572300 | 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. |
| 11892638 | 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. |
| 24423049 | 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. |
| 11436885 | 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. |
| 20403933 | 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. |
| 23603648 | 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. |
| 22684159 | 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. |
| 23532866 | 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. |
| 21444601 | 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. |
| 23966025 | 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. |
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| 14535904 | 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. |
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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. Ultrasound: Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Participant sex was not collected | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
Ultrasound: Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
|
|
| Secondary | Number of Attempts- Per Direct Observation | Defined as the number of times a lumbar puncture needle is removed from skin and reinserted or a new needle is inserted. | Posted | Median | Inter-Quartile Range | number of attempts | Outcome measured at the time of the procedure (same day) |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Pre-Procedural Ultrasound | 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. Ultrasound: Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace. | 0 | 38 | 0 | 38 | 0 | 38 |
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