Spinal PunctureNCT03167190
Ultrasound-Assisted Lumbar Puncture
A study testing Point-of-care ultrasound and Traditional Landmark-based Lumbar Puncture in people with Spinal Puncture and Diagnostic Imaging, run by Mayo Clinic at 1 site in United States.
Trial summary
Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Puncture, Diagnostic Imaging
- What is being tested?
- Point-of-care ultrasound and Traditional Landmark-based Lumbar Puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018
- Males or females 18 years of age or older
- Patients who have been identified as requiring a lumbar puncture for any therapeutic or diagnostic or therapeutic indication, as decided by the neurology staff physicians, residents, or advanced practice providers.
Who cannot join
- Patients who are not capable of providing consent for participation in research and do not have an authorized relative or power of attorney to consent in their stead.
- Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact.
- Patients with known abnormal lumbar spinal anatomy or prior extensive surgical fusion such that fluoroscopic or CT guidance is determined to be more clinically appropriate by the treating physicians.
- BMI greater than 60
- Absolute contraindication to lumbar puncture such as uncorrected coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-localized Landmark Identification in Hospitalized Patients Requiring Lumbar Puncture: Implications for Safety, Quality, and Procedural Success
Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. This study intends to see whether by using ultrasound there is increased success rate, decreased need for additional procedures, and less discomfort during the procedure.
- Conditions
- Spinal Puncture, Diagnostic Imaging
- Being tested
- Point-of-care ultrasound, Traditional Landmark-based Lumbar Puncture
- Keywords
- Point of Care Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundProcedure or surgery
A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.
Traditional Landmark-based Lumbar PunctureProcedure or surgery
Palpation of anatomical landmarks to identify midline and interspinous space
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Traditional landmark-based lumbar puncture technique by palpation Receives: Procedure: Traditional Landmark-based Lumbar Puncture |
| Experimental (ultrasound) | Experimental | Use of point-of-care ultrasound to identify bony landmarks. Receives: Procedure: Point-of-care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Procedural Duration
This is defined by number of minutes from initiating of patient positioning (prior to evaluation of the anatomical landmarks) to first flow of cerebrospinal fluid (CSF).
Measured: Approximately 1 hour
Secondary outcomes (7)
Number of Procedures Considered to be Failures
As defined by inability to obtain cerebrospinal fluid despite multiple attempts, terminated at the discretion of the procedurist as would otherwise be clinically determined.
Measured: Approximately 1 hour
Number of Fluoroscopically Guided or CT Guided Lumbar Punctures
In the event of ultrasound procedural failure by clinician
Measured: Approximately 7 days
Total number of unique skin punctures
This will be defined by the needle bevel completely exiting and skin and being re-inserted, during the duration of the procedure, whether the procedure is ultimately successful or not.
Measured: Approximately 1 day
Procedurist reported ease of the procedure
Procedurist reported ease of the procedure will be reported by a 10 cm visual analog scale, with 0=easy and 10=very difficult.
Measured: Approximately 1 day
Patient reported discomfort
Patient reported discomfort will be reported by a 10 cm visual analog scale, with 0=no discomfort and 10=extreme discomfort.
Measured: Approximately 1 day
Number of red blood cells in collected CSF
This will be abstracted manually from the patient's electronic medical record.
Measured: Approximately 1 day
Hospital Length of Stay
This will be abstracted manually from the patient's electronic medical record.
Measured: Approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start25 May 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: Failed to meet target enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal PunctureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled into the control group (Landmark-based palpation and skin marking) vs the experimental group (ultrasound assisted identification of bony landmarks and skin marking).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael P Boniface, Mayo Clinic
- Investigators
- Michael P Boniface, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167190
- Sponsor's protocol ID
- 17-000511
- Status last verified
- Jan 2020
- First submitted
- 24 May 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edwards C, Leira EC, Gonzalez-Alegre P. Residency training: a failed lumbar puncture is more about obesity than lack of ability. Neurology. 2015 Mar 10;84(10):e69-72. doi: 10.1212/WNL.0000000000001335.
PubMed 25754807Engedal TS, Ording H, Vilholm OJ. Changing the needle for lumbar punctures: results from a prospective study. Clin Neurol Neurosurg. 2015 Mar;130:74-9. doi: 10.1016/j.clineuro.2014.12.020. Epub 2015 Jan 6.
PubMed 25590665Ferre 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 17349903Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
PubMed 11172514Huang MY, Lin AP, Chang WH. Ultrasound-assisted localization for lumbar puncture in the ED. Am J Emerg Med. 2008 Oct;26(8):955-7. doi: 10.1016/j.ajem.2008.03.007. No abstract available.
PubMed 18926360Lahham S, Schmalbach P, Wilson SP, Ludeman L, Subeh M, Chao J, Albadawi N, Mohammadi N, Fox JC. Prospective evaluation of point-of-care ultrasound for pre-procedure identification of landmarks versus traditional palpation for lumbar puncture. World J Emerg Med. 2016;7(3):173-7. doi: 10.5847/wjem.j.1920-8642.2016.03.002.
PubMed 27547275Nomura 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 17901137Peterson MA, Pisupati D, Heyming TW, Abele JA, Lewis RJ. Ultrasound for routine lumbar puncture. Acad Emerg Med. 2014 Feb;21(2):130-6. doi: 10.1111/acem.12305.
PubMed 24673668Williams S, Khalil M, Weerasinghe A, Sharma A, Davey R. How to do it: bedside ultrasound to assist lumbar puncture. Pract Neurol. 2017 Jan;17(1):47-50. doi: 10.1136/practneurol-2016-001463. Epub 2016 Nov 28.
PubMed 27895189
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-localized Landmark Identification in Hospitalized Patients Requiring Lumbar Puncture: Implications for Safety, Quality, and Procedural Success
- ClinicalTrials.gov ID
- NCT03167190
- Acronym / sponsor ID
- 17-000511
- Conditions
- Spinal Puncture, Diagnostic Imaging
- Keywords
- Point of Care Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to meet target enrollment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. This study intends to see whether by using ultrasound there is increased success rate, decreased need for additional procedures, and less discomfort during the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be enrolled into the control group (Landmark-based palpation and skin marking) vs the experimental group (ultrasound assisted identification of bony landmarks and skin marking).
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Traditional Landmark-based Lumbar PunctureTraditional landmark-based lumbar puncture technique by palpation |
| Experimental (ultrasound) | Experimental | Procedure: Point-of-care ultrasoundUse of point-of-care ultrasound to identify bony landmarks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018
- Males or females 18 years of age or older
- Patients who have been identified as requiring a lumbar puncture for any therapeutic or diagnostic or therapeutic indication, as decided by the neurology staff physicians, residents, or advanced practice providers.
Key exclusion criteria (5 listed)
- Patients who are not capable of providing consent for participation in research and do not have an authorized relative or power of attorney to consent in their stead.
- Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact.
- Patients with known abnormal lumbar spinal anatomy or prior extensive surgical fusion such that fluoroscopic or CT guidance is determined to be more clinically appropriate by the treating physicians.
- BMI greater than 60
- Absolute contraindication to lumbar puncture such as uncorrected coagulopathy
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 |
|---|---|---|
| Point-of-care ultrasoundA point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes. | Procedure or surgery | Experimental (ultrasound) |
| Traditional Landmark-based Lumbar PuncturePalpation of anatomical landmarks to identify midline and interspinous space | Procedure or surgery | Control |
Primary outcome
Mean Procedural Duration
Time frame: Approximately 1 hour
This is defined by number of minutes from initiating of patient positioning (prior to evaluation of the anatomical landmarks) to first flow of cerebrospinal fluid (CSF).
7 secondary outcomes
Number of Procedures Considered to be Failures
Time frame: Approximately 1 hour
Number of Fluoroscopically Guided or CT Guided Lumbar Punctures
Time frame: Approximately 7 days
Total number of unique skin punctures
Time frame: Approximately 1 day
Procedurist reported ease of the procedure
Time frame: Approximately 1 day
Patient reported discomfort
Time frame: Approximately 1 day
Number of red blood cells in collected CSF
Time frame: Approximately 1 day
Hospital Length of Stay
Time frame: Approximately 1 month
Results and safety
The study was stopped early (reason given: Failed to meet target enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Background: PubMed 25754807Edwards C, Leira EC, Gonzalez-Alegre P. Residency training: a failed lumbar puncture is more about obesity than lack of ability. Neurology. 2015 Mar 10;84(10):e69-72. doi: 10.1212/WNL.0000000000001335.
- Background: PubMed 25590665Engedal TS, Ording H, Vilholm OJ. Changing the needle for lumbar punctures: results from a prospective study. Clin Neurol Neurosurg. 2015 Mar;130:74-9. doi: 10.1016/j.clineuro.2014.12.020. Epub 2015 Jan 6.
- 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 11172514Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.
- Background: PubMed 18926360Huang MY, Lin AP, Chang WH. Ultrasound-assisted localization for lumbar puncture in the ED. Am J Emerg Med. 2008 Oct;26(8):955-7. doi: 10.1016/j.ajem.2008.03.007. No abstract available.
- Background: PubMed 27547275Lahham S, Schmalbach P, Wilson SP, Ludeman L, Subeh M, Chao J, Albadawi N, Mohammadi N, Fox JC. Prospective evaluation of point-of-care ultrasound for pre-procedure identification of landmarks versus traditional palpation for lumbar puncture. World J Emerg Med. 2016;7(3):173-7. doi: 10.5847/wjem.j.1920-8642.2016.03.002.
- 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 24673668Peterson MA, Pisupati D, Heyming TW, Abele JA, Lewis RJ. Ultrasound for routine lumbar puncture. Acad Emerg Med. 2014 Feb;21(2):130-6. doi: 10.1111/acem.12305.
- Background: PubMed 27895189Williams S, Khalil M, Weerasinghe A, Sharma A, Davey R. How to do it: bedside ultrasound to assist lumbar puncture. Pract Neurol. 2017 Jan;17(1):47-50. doi: 10.1136/practneurol-2016-001463. Epub 2016 Nov 28.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Michael P Boniface, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound and Traditional Landmark-based Lumbar Puncture in people with Spinal Puncture and Diagnostic Imaging, run by Mayo Clinic 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Jan 2020. 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?
The study was stopped early (reason given: Failed to meet target enrollment). Results are not available in the source record.
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?
Mean Procedural Duration (time frame: Approximately 1 hour). 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 NCT03167190, which also lists 9 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 9 Jan 2020.