80 Participants NeededMy employer runs this trial

Ultrasound for Spinal Tap

(HELP Trial)

DH
Overseen ByDonald H Arnold, MD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using ultrasound, a type of imaging technology, to guide spinal taps can improve the success of collecting cerebrospinal fluid (CSF) for diagnosis. The goal is to determine if this method helps doctors obtain better samples to manage a patient's condition. The trial includes two groups: one using ultrasound guidance and the other not. It seeks infants under 12 months old who need a spinal tap and are in stable health. As an unphased study, this trial offers the chance to contribute to innovative research that could enhance medical procedures for infants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound technique is safe for lumbar puncture?

Research has shown that using ultrasound to guide spinal taps is generally safe and improves the procedure. For example, one study found that ultrasound reduces the chances of failed or difficult attempts during a spinal tap, leading to fewer complications like bleeding or headaches afterward. Another study examined 562 spinal taps and found that most were successful and safe, particularly with ultrasound guidance. Overall, ultrasound makes the procedure quicker and more successful, suggesting it is well-tolerated by patients. These findings indicate that ultrasound-assisted spinal taps are a safe option for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about using ultrasound for spinal taps because it offers a non-invasive way to guide the procedure. Unlike traditional spinal taps, which rely on touch and anatomical landmarks, ultrasound provides real-time imaging of the spinal canal. This could potentially increase accuracy and reduce the discomfort and risk for infants undergoing lumbar punctures. By offering a clearer view of the spine, ultrasound could make spinal taps safer and more efficient, which is why there's a buzz around this technique.

What evidence suggests that ultrasound is effective for increasing CSF acquisition rate in spinal taps?

Research has shown that ultrasound guidance increases the success of spinal taps. One study reported a 92.7% success rate with ultrasound, compared to 68.3% without it. Another study found that ultrasound not only sped up the procedure but also reduced complications. Several studies report a success rate of about 90% for ultrasound-guided spinal taps. In this trial, participants in the experimental arm will undergo spinal taps with ultrasound guidance, while the control group will have the procedure without ultrasound assistance. This suggests that ultrasound improves the likelihood of successfully obtaining cerebrospinal fluid, crucial for diagnosing medical conditions.24678

Are You a Good Fit for This Trial?

This trial is for people who need a lumbar puncture (spinal tap), possibly due to infections like staphylococcal meningitis, fever, or sepsis. Participants are likely adults needing this procedure as part of their care.

Inclusion Criteria

My blood pressure and heart function are stable.
I am having a lumbar puncture for diagnostic testing.
I am younger than 12 months old.

Exclusion Criteria

I have a spinal abnormality or have had spinal surgery before.
I have symptoms that show my health is currently unstable.
I am older than 12 months and 1 day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar puncture with or without ultrasound assistance to evaluate the acquisition rate of interpretable CSF.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the lumbar puncture procedure.

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Ultrasound Contrast

Trial Overview

The study tests whether using ultrasound during a lumbar puncture helps doctors collect spinal fluid more successfully and safely by guiding needle placement with imaging.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: UltrasoundExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

Ultrasound-guided lumbar puncture improves success rate ...

The ultrasound-guided LP group showed higher success rate (92.7% vs 68.3%, p < 0.05) and less duration of time (17.02 vs 37.63 minutes, p < 0.05) compared with ...

The Role of Ultrasound Guided Lumbar Puncture in ... - Currents

Studies highlight several key benefits of ultrasound guidance, including improved success rates, reduced procedural time, fewer complications, ...

Bedside Ultrasound on the Effectiveness of Lumbar ...

The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture. An ...

Update on Lumbar Puncture and Ultrasound of the Spine ...

It is successful in 90% of patients compared to landmark-based LP's 81.4%. These benefits have been backed by a 2020 article on overweight ...

'UltraGUD LP'—ultrasound guided diagnostic LP—a ...

This study (UltraGUD LP) aimed to compare the effectiveness of ultrasound-guided LP (US-LP) versus landmark-based LP (LM-LP) in an outpatient neurology setting.

Ultrasound guidance for lumbar puncture - PMC - NIH

Abstract. Purpose of review: To review the literature and describe techniques to use ultrasound to guide performance of lumbar puncture (LP).

Lumbar puncture (spinal tap)

Although a lumbar puncture, also known as a spinal tap, is generally safe, it does carry some risks. These include: Post-lumbar puncture ...

FAQ about Lumbar Puncture

Gauges smaller than 22 result in poor flow of spinal fluid. B. Needle type. Standard LP trays have a 'traumatic' or 'cutting' (Quincke) needle.