Clinical Trials Directory

Trials / Terminated

TerminatedNCT03815045

Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Dartmouth-Hitchcock Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
PROCEDURELandmark-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.
PROCEDUREUltrasound-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.

Timeline

Start date
2017-07-20
Primary completion
2023-03-10
Completion
2023-12-31
First posted
2019-01-24
Last updated
2024-01-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03815045. Inclusion in this directory is not an endorsement.