Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Not Applicable

Terminated

• Conditions: Lumbar Puncture
• Interventions: Procedure: Landmark-based lumbar puncture; Procedure: Ultrasound-guided lumbar puncture

• Registration Number: NCT03815045
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief 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.

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2023-03-10
• Status Verified: 2023-09
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Landmark-based lumbar puncture	Landmark-based lumbar puncture	Landmark-based LP
Ultrasound-guided lumbar puncture	Ultrasound-guided lumbar puncture	Ultrasound-guided LP

Primary Outcome Measures

Name	Time	Method
Success rate of obtaining CSF within 3 attempts	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

Secondary Outcome Measures

Name	Time	Method
Number of attempts to obtain CSF	Immediately following consent, during baseline visit	The number of attempts it takes to obtain CSF
Incidence of traumatic tap	Time taken to run analysis of CSF RBC count, approximately within 1 day	defined as CSF RBC count \>400/ml
Pain after the procedure	Immediately post-procedure, approximately 5 minutes	Universal Pain Assessment Tool: Subject-reported pain level as rated on a scale of 0 - 10. Lower score indicates a better outcome.
Occurrence of post LP headache	Phone call within 72 hours of procedure	Subject-reported incidence of post LP headache within 72 hours
Time to completion of LP, in minutes	Immediately following consent, during baseline visit, approximately 1 hour	Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States