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 — PROCEDURE
    Pre-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 — OTHER
    Anatomical 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-assisted
    Participants 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-Guided
    The 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)

FacilityCityStateZIPSite coordinators
Cooper University HospitalCamdenNew Jersey08103-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-

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