Lumbar PunctureNCT03815045
Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
A study testing Landmark-based lumbar puncture and Ultrasound-guided lumbar puncture in people with Lumbar Puncture, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Puncture
- What is being tested?
- Landmark-based lumbar puncture and Ultrasound-guided lumbar puncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for LP through Neurology's LP clinic
- 18 years of age or older
- Able to understand the description of procedure and provide informed consent
Who cannot join
- Any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. This includes subjects with spinal cord stimulators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. The primary objective of study is to compare the success rate of obtaining CSF using Ultrasound guided technique against the Traditional Landmark based approach. Secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.
Read the detailed description
Seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be conducted in the Neurology clinic. For subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. For subjects in the ultrasound group, site entry will be done using ultrasound guidance. Success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.
- Conditions
- Lumbar Puncture
- Being tested
- Landmark-based lumbar puncture, Ultrasound-guided lumbar puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmark-based lumbar punctureProcedure or surgery
Traditional landmark based lumbar puncture involves palpating spinous processes on the back and finding the inter-spinous space which is the site of needle entry to gain access to the thecal sac. Finding this space may be difficult by palpation, especially when subjects undergoing the procedure are obese, elderly, have had prior back surgery, or if the patient is positioned incorrectly.
Ultrasound-guided lumbar punctureProcedure or surgery
Ultrasound guided lumbar puncture is a novel technique being increasingly utilized by emergency physicians, pediatricians and anesthesiologists. In this technique, an ultrasound probe is used to visualize the inter-spinous space. This space can be marked on the skin as the potential point of entry. This could potentially make it easier when patient factors make it difficult to palpate and find the site of entry.
| Study group | Role | What they receive |
|---|---|---|
| Landmark-based lumbar puncture | Active comparator | Landmark-based LP Receives: Procedure: Landmark-based lumbar puncture |
| Ultrasound-guided lumbar puncture | Active comparator | Ultrasound-guided LP Receives: Procedure: Ultrasound-guided lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of obtaining CSF within 3 attempts
The success of the procedure is defined as the ability to obtain CSF within 3 attempts via Landmark based LP vs Ultrasound guided LP
Measured: During the baseline visit, approximately 1 hour
Secondary outcomes (5)
Time to completion of LP, in minutes
Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF
Measured: Immediately following consent, during baseline visit, approximately 1 hour
Number of attempts to obtain CSF
The number of attempts it takes to obtain CSF
Measured: Immediately following consent, during baseline visit
Incidence of traumatic tap
defined as CSF RBC count >400/ml
Measured: Time taken to run analysis of CSF RBC count, approximately within 1 day
Pain after the procedure
Universal Pain Assessment Tool: Subject-reported pain level as rated on a scale of 0 - 10. Lower score indicates a better outcome.
Measured: Immediately post-procedure, approximately 5 minutes
Occurrence of post LP headache
Subject-reported incidence of post LP headache within 72 hours
Measured: Phone call within 72 hours of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start20 Jul 2017
- Primary completion10 Mar 2023
- Study completion31 Dec 2023
Why it stopped: An interim analysis was conducted, and no difference was found between traditional lumbar punctures and ultrasound-guided lumbar punctures. The study was subsequently terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815045
- Sponsor's protocol ID
- D17180
- Status last verified
- Sep 2023
- First submitted
- 22 Jan 2019
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
- ClinicalTrials.gov ID
- NCT03815045
- Acronym / sponsor ID
- D17180
- Conditions
- Lumbar Puncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An interim analysis was conducted, and no difference was found between traditional lumbar punctures and ultrasound-guided lumbar punctures. The study was subsequently terminated.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Jan 2019 (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.
Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. The primary objective of study is to compare the success rate of obtaining CSF using Ultrasound guided technique against the Traditional Landmark based approach. Secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.
Detailed description
Seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be conducted in the Neurology clinic. For subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. For subjects in the ultrasound group, site entry will be done using ultrasound guidance. Success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landmark-based lumbar puncture | Active comparator | Procedure: Landmark-based lumbar punctureLandmark-based LP |
| Ultrasound-guided lumbar puncture | Active comparator | Procedure: Ultrasound-guided lumbar punctureUltrasound-guided LP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for LP through Neurology's LP clinic
- 18 years of age or older
- Able to understand the description of procedure and provide informed consent
Key exclusion criteria (1 listed)
- Any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. This includes subjects with spinal cord stimulators.
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 |
|---|---|---|
| Landmark-based lumbar punctureTraditional landmark based lumbar puncture involves palpating spinous processes on the back and finding the inter-spinous space which is the site of needle entry to gain access to the thecal sac. Finding this space may be difficult by palpation, especially when subjects undergoing the procedure are obese, elderly, have had prior back surgery, or if the patient is positioned incorrectly. | Procedure or surgery | Landmark-based lumbar puncture |
| Ultrasound-guided lumbar punctureUltrasound guided lumbar puncture is a novel technique being increasingly utilized by emergency physicians, pediatricians and anesthesiologists. In this technique, an ultrasound probe is used to visualize the inter-spinous space. This space can be marked on the skin as the potential point of entry. This could potentially make it easier when patient factors make it difficult to palpate and find the site of entry. | Procedure or surgery | Ultrasound-guided lumbar puncture |
Primary outcome
Success rate of obtaining CSF within 3 attempts
Time frame: During the baseline visit, approximately 1 hour
The success of the procedure is defined as the ability to obtain CSF within 3 attempts via Landmark based LP vs Ultrasound guided LP
5 secondary outcomes
Time to completion of LP, in minutes
Time frame: Immediately following consent, during baseline visit, approximately 1 hour
Number of attempts to obtain CSF
Time frame: Immediately following consent, during baseline visit
Incidence of traumatic tap
Time frame: Time taken to run analysis of CSF RBC count, approximately within 1 day
Pain after the procedure
Time frame: Immediately post-procedure, approximately 5 minutes
Occurrence of post LP headache
Time frame: Phone call within 72 hours of procedure
Results and safety
The study was stopped early (reason given: An interim analysis was conducted, and no difference was found between traditional lumbar punctures and ultrasound-guided lumbar punctures. The study was subsequently terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Landmark-based lumbar puncture and Ultrasound-guided lumbar puncture in people with Lumbar Puncture, run by Dartmouth-Hitchcock Medical Center 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 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: stopped early, as of the sponsor's last update on 31 Jan 2024. 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: An interim analysis was conducted, and no difference was found between traditional lumbar punctures and ultrasound-guided lumbar punctures. The study was subsequently terminated.). 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?
Success rate of obtaining CSF within 3 attempts (time frame: During the baseline visit, approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024.