Ultrasound-assisted vs Palpation-guided Lumbar Punctures
Part of paid clinical trials in Camden, New Jersey.
- Sponsor
- The Cooper Health System
- Study ID
- NCT07824284
- Status
- Enrolling By Invitation
Conditions
- Lumbar Puncture
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ultrasound-Assisted Lumbar Puncture — PROCEDUREPre-procedural point-of-care ultrasound is used to identify the midline, appropriate interspinous space, and estimated needle depth. The selected insertion site is marked, after which lumbar puncture is performed using standard sterile technique and institutional protocols.
- Standard Palpation-Guided Lumbar Puncture — OTHERAnatomical landmarks are identified by palpation of bony landmarks to select the lumbar puncture insertion site. Lumbar puncture is then performed using standard sterile technique and institutional protocols without pre-procedural ultrasound localization.
Study Details
The goal of this randomized clinical trial is to determine whether ultrasound-assisted lumbar puncture improves first-needle insertion success compared with the standard palpation technique in adults undergoing a clinically indicated lumbar puncture. The primary question is whether pre-procedural ultrasound localization increases the likelihood of successful cerebrospinal fluid collection on the first needle insertion. The study will also evaluate overall procedural success, the number of needle insertions and redirections, procedure time, the need for subsequent image-guided lumbar puncture, traumatic tap, procedural and post-procedural pain, and post-dural puncture headache. Participants will be randomly assigned in a 1:1 ratio to undergo lumbar puncture using either pre-procedural ultrasound localization or standard palpation of anatomical landmarks.
Key Dates
- First listed
- Sep 17, 2026
- Start date
- Apr 25, 2026
- Status verified
- Sep 2026
- Primary completion
- Jun 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 132 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Ultrasound-assistedParticipants undergo pre-procedural point-of-care ultrasound to identify and mark the spinal midline, selected interspinous spaces and to estimate the depth to the target. The lumbar puncture is then performed using standard technique without real-time ultrasound guidance.
- Active Comparator: Standard Palpation-GuidedThe lumbar puncture insertion site is selected by palpation of anatomical landmarks without pre-procedural ultrasound localization. The lumbar puncture is then performed using standard technique.
Primary Outcome Measure
First Attempt Lumbar Puncture Success [ Time Frame: During the lumbar puncture procedure ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | - |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | - |
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