Traumatic Lumbar PunctureNCT02133066

The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Spinal Taps

A study testing Bedside Ultrasound-Assisted Site Marking, Mindray M7 Ultrasound and Routine lumbar puncture in people with Traumatic Lumbar Puncture, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages Up to 6 monthsHealthy volunteers can take part
Conditions the study is for: Traumatic Lumbar Puncture
What is being tested?: Bedside Ultrasound-Assisted Site Marking, Mindray M7 Ultrasound and Routine lumbar puncture
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 1 siteUnited States
Study dates: May 2014to Jan 2017
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 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

Known spinal cord abnormality (e.g., tethered cord, spina bifida)

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia Emergency Department
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Traumatic Lumbar Puncture
Being tested: Bedside Ultrasound-Assisted Site Marking, Mindray M7 Ultrasound, Routine lumbar puncture
Keywords: Ultrasound, Lumbar Puncture, Spinal Tap, Pediatric, Infant, Bedside Ultrasonography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bedside Ultrasound-Assisted Site MarkingProcedure or surgery
Also called Mindray M7 Ultrasound
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 UltrasoundDevice
Also called M7/M7T Diagnostic 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 punctureProcedure or surgery
Lumbar puncture will be performed per routine standard of care

Study groups in NCT02133066
Study group	Role	What they receive
US-Assisted site marking for Lumbar Punctures (LP)	Active comparator	Mindray M7 Ultrasound marking Receives: Procedure: Bedside Ultrasound-Assisted Site Marking; Device: Mindray M7 Ultrasound
Routine lumbar puncture	Placebo comparator	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 Receives: Procedure: Routine lumbar puncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30 minutes

Secondary outcomes (3)

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
Measured: 30 minutes
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.
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 2 days
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.
Measured: Participants will be followed until discontinuation of antibiotics, an expected average of 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jan 2017

First posted7 May 2014 (estimated)
Study startMay 2014
Primary completionFeb 2016
Study completionJan 2017

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 (17)Papers the sponsor has linked to this study.
Other trials for Traumatic Lumbar PunctureStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02133066
Sponsor's protocol ID: 13-010667
Status last verified: Aug 2017
First submitted: 2 May 2014
Last updated: 31 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20403933
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.
PubMed 16510670
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.
PubMed 21444601
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.
PubMed 11692234
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.
PubMed 18810417
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.
PubMed 17349903
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.
PubMed 11892638
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.
PubMed 14984904
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.
PubMed 17321005
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.
PubMed 21492866
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.
PubMed 17901137
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.
PubMed 22684159
Pappano D. "Traumatic tap" proportion in pediatric lumbar puncture. Pediatr Emerg Care. 2010 Jul;26(7):487-9. doi: 10.1097/PEC.0b013e3181e5bedd.
PubMed 20577138
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.
PubMed 15707816
Pinheiro JM, Furdon S, Ochoa LF. Role of local anesthesia during lumbar puncture in neonates. Pediatrics. 1993 Feb;91(2):379-82.
PubMed 8424014

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02133066
Acronym / sponsor ID: 13-010667
Conditions: Traumatic Lumbar Puncture
Keywords: Ultrasound, Lumbar Puncture, Spinal Tap, Pediatric, Infant, Bedside Ultrasonography
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Study start: May 2014
Primary completion: Feb 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 7 May 2014 (estimated)
Results: Posted 31 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
US-Assisted site marking for Lumbar Punctures (LP)	Active comparator	Procedure: Bedside Ultrasound-Assisted Site Marking, Device: Mindray M7 UltrasoundMindray M7 Ultrasound marking
Routine lumbar puncture	Placebo comparator	Procedure: Routine lumbar punctureThese 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

Who may qualify

Ages: Up to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Known spinal cord abnormality (e.g., tethered cord, spina bifida)

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
Bedside Ultrasound-Assisted Site MarkingAlso: Mindray M7 UltrasoundPatient 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.	Procedure or surgery	US-Assisted site marking for Lumbar Punctures (LP)
Mindray M7 UltrasoundAlso: M7/M7T Diagnostic UltrasoundPatient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap	Device	US-Assisted site marking for Lumbar Punctures (LP)
Routine lumbar punctureLumbar puncture will be performed per routine standard of care	Procedure or surgery	Routine lumbar puncture

Primary outcome

Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
Time frame: 30 minutes
First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group

3 secondary outcomes

Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group
Time frame: 30 minutes
Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 2 days
Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients
Time frame: Participants will be followed until discontinuation of antibiotics, an expected average of 2 days

Results and safety

Results posted to the registry on 31 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
US-Assisted Site Marking for LP	64	64
Routine Lumbar Puncture	64	64

Primary outcome: Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group

Time frame: 30 minutes. Number (95% Confidence Interval). Unit: percent success

Measure	US-Assisted Site Marking for LP n = 64	Routine Lumbar Puncture n = 64
Value	58 (50 to 70)	31 (19 to 39)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
US-Assisted Site Marking for LP	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Routine Lumbar Puncture	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 16510670Baxter 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.
Background: PubMed 21444601Bruccoleri 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.
Background: PubMed 11692234Coley 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.
Background: PubMed 18810417Dietrich 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.
Background: PubMed 17349903Ferre 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.
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 14984904Lam 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.
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 21492866Nigrovic 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.
Background: PubMed 17901137Nomura 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.
Background: PubMed 22684159Oncel 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.

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.

Aaron E Chen, MD principal investigator

CHOP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 1 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 31 Aug 2017. 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. Some participants in this study may receive a placebo. 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 31 Aug 2017). 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?

Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group (time frame: 30 minutes). 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 NCT02133066, which also lists 17 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 31 Aug 2017.