Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Lumbar Puncture Clinical Trial

Official title:

Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03815045
• Other study ID #: D17180
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 31, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lumbar Puncture
• Wounds and Injuries

Intervention

Procedure:
• Landmark-based lumbar puncture
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 puncture
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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the baseline visit, approximately 1 hour
Secondary	Time to completion of LP, in minutes	Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF	Immediately following consent, during baseline visit, approximately 1 hour
Secondary	Number of attempts to obtain CSF	The number of attempts it takes to obtain CSF	Immediately following consent, during baseline visit
Secondary	Incidence of traumatic tap	defined as CSF RBC count >400/ml	Time taken to run analysis of CSF RBC count, approximately within 1 day
Secondary	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.	Immediately post-procedure, approximately 5 minutes
Secondary	Occurrence of post LP headache	Subject-reported incidence of post LP headache within 72 hours	Phone call within 72 hours of procedure