Spinal; Puncture, ComplicationsNCT02373774
Ultrasound vs Palpation for Infant Lumbar Puncture
A study testing Ultrasound in people with Spinal; Puncture, Complications, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 daysHealthy volunteers can take part
- Conditions the study is for
- Spinal; Puncture, Complications
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient is less than 90 days old.
- Patient is receiving a lumbar puncture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture
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.
Read the detailed description
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:
- 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.
- Conditions
- Spinal; Puncture, Complications
- Being tested
- Ultrasound
- Keywords
- infant, lumbar puncture, patient safety, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called (Zonare Z1.pro and/or Sonosite Mturbo)
Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome measured on the same day of the procedure
Secondary outcomes (1)
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.
Measured: Outcome measured at the time of the procedure (same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Spinal; Puncture, ComplicationsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kessler, Columbia University
- Investigators
- David O Kessler, MD, MSc, Principal investigator, Columbia UniversityGerald Behr, MD, Principal investigator, Columbia UniversityPeter S Dayan, MD, MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373774
- Sponsor's protocol ID
- AAAO3705
- Status last verified
- Oct 2023
- First submitted
- 7 Feb 2015
- Last updated
- 24 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 17047467Jain 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.
PubMed 24470644Kessler 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.
PubMed 23439901Nigrovic 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.
PubMed 17321005Glatstein 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.
PubMed 21622691Bonadio 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.
PubMed 24188604Duniec 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.
PubMed 23572300Furness 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.
PubMed 11892638Shekelle 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.
PubMed 24423049Coley 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.
PubMed 11436885Abo 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.
PubMed 20403933Lo 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.
PubMed 23603648Oncel 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.
PubMed 22684159Shaikh 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.
PubMed 23532866Bruccoleri 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.
PubMed 21444601
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Visualization vs Palpation Technique for Infant Lumbar Puncture
- ClinicalTrials.gov ID
- NCT02373774
- Acronym / sponsor ID
- AAAO3705
- Conditions
- Spinal; Puncture, Complications
- Keywords
- infant, lumbar puncture, patient safety, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 24 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: UltrasoundParticipants 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. |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient is less than 90 days old.
- Patient is receiving a lumbar puncture
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAlso: (Zonare Z1.pro and/or Sonosite Mturbo)Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace. | Device | Pre-Procedural Ultrasound |
Primary outcome
Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts
Time frame: Outcome measured on the same day of the procedure
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.
1 secondary outcome
Number of Attempts- Per Direct Observation
Time frame: Outcome measured at the time of the procedure (same day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17047467Alpern 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.
- Background: PubMed 24470644Jain 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.
- Background: PubMed 23439901Kessler 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.
- Background: PubMed 17321005Nigrovic 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.
- Background: PubMed 21622691Glatstein 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.
- Background: PubMed 24188604Bonadio 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.
- Background: PubMed 23572300Duniec 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.
- Background: PubMed 11892638Furness 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.
- Background: PubMed 24423049Shekelle 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.
- Background: PubMed 11436885Coley 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.
- Background: PubMed 20403933Abo 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.
- Background: PubMed 23603648Lo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David O Kessler, MD, MSc principal investigator
Columbia University
Gerald Behr, MD principal investigator
Columbia University
Peter S Dayan, MD, MSc principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Spinal; Puncture, Complications, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Puncture Success - Composite Score Including Lab Results and Reported Attempts (time frame: Outcome measured on the same day of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373774, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.