Lumbar Puncture
Conditions
Keywords
lumbar puncture, ultrasound-guided lumbar puncture, ultrasound-assisted lumbar puncture, point-of-care ultrasound, palpation-guided lumbar puncture, first-attempt success, post-dural puncture headache, multicenter, inpatient, outpatient
Brief summary
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.
Detailed description
Lumbar puncture (LP) is a commonly performed diagnostic and therapeutic procedure. The standard approach relies on palpation of surface anatomical landmarks to identify an appropriate intervertebral space for needle insertion. When landmarks are difficult to identify, LP may require multiple needle insertions or redirections, cause greater patient discomfort, delay cerebrospinal fluid (CSF) collection, or require a subsequent image-guided procedure. Point-of-care ultrasound can be used before needle insertion to identify the spinal midline and an appropriate interspinous space and to estimate the depth to the target. Previous studies of ultrasound-assisted LP have produced variable findings regarding procedural success, efficiency, traumatic tap, and patient discomfort. Patient-centered complications, including post-dural puncture headache, have been less extensively evaluated. This is a prospective, multicenter, parallel-group randomized controlled trial involving adults undergoing a clinically indicated LP in an inpatient or outpatient setting. Participants will be randomly assigned in a 1:1 ratio to pre-procedural ultrasound localization or standard palpation of anatomical landmarks. In the ultrasound-assisted group, point-of-care ultrasound will be used before needle insertion to identify the spinal midline and interspinous space and estimate the depth to the target. The selected insertion site will then be marked, and the LP will proceed using standard technique; the needle will not be advanced under real-time ultrasound guidance. In the standard palpation group, the insertion site will be identified by palpation without pre-procedural ultrasound. Other aspects of the procedure and post-procedure care will follow standard clinical practice at each participating site. The trial will determine whether pre-procedural ultrasound localization improves first-needle insertion success and reduces procedural burden and complications compared with standard palpation.
Interventions
PROCEDUREUltrasound-Assisted Lumbar Puncture
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.
OTHERStandard Palpation-Guided Lumbar Puncture
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.
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years old and above * Patients requiring lumbar puncture for diagnostic or therapeutic purposes as determined by the treating physician * Must be able to give informed consent, or if unable, have a legally authorized representative provide written consent
Exclusion criteria
* Inability to safely undergo bedside lumbar puncture (either ultrasound-guided or palpation guided) as determined by the treating physician * Known contraindications to lumbar puncture, including: * Increased intracranial pressure with risk of herniation * Infection at the lumbar puncture site * Known coagulopathy or platelet count \<50,000 µL * Received DVT prophylaxis on the day of planned lumbar puncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Attempt Lumbar Puncture Success | During the lumbar puncture procedure | First-attempt success is defined as successful cerebrospinal fluid (CSF) return following a single skin puncture, without complete withdrawal and reinsertion of the lumbar puncture needle. Up to three in-situ needle redirections are permitted. A redirection is defined as partial withdrawal and readvancement of the needle without removal from the skin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Lumbar Puncture Success | During the initial lumbar puncture encounter | Successful CSF return during the initially assigned lumbar puncture procedure, regardless of the number of needle reinsertions or redirections and without requiring a subsequent fluoroscopy-guided lumbar puncture. |
| Number of Needle Reinsertions | During the lumbar puncture procedure | Number of times the lumbar puncture needle is completely withdrawn from the skin and reinserted during the procedure. |
| Number of Needle Redirections | During the lumbar puncture procedure | Number of times the needle is partially withdrawn and readvanced along a different trajectory without complete removal from the skin. |
| Procedure Time | During the lumbar puncture procedure | Elapsed time in minutes from initiation of landmark identification using ultrasound or palpation until CSF return. For an unsuccessful procedure, time is measured until termination of the assigned bedside procedure. |
| Time to CSF Return | During the lumbar puncture process | Time in minutes from the first skin puncture with the lumbar puncture needle to successful CSF return. |
| Incidence of Traumatic Tap | During the lumbar puncture procedure | Proportion of participants with a traumatic lumbar puncture, defined as a CSF red blood cell count ≥400 cells/µL in the first collection tube with a decrease in red blood cell count in the fourth tube. |
| Incidence of Radicular Pain During Lumbar Puncture | During the lumbar puncture procedure | Proportion of participants reporting radicular pain during the lumbar puncture procedure. |
| Post-Procedural Back Pain | Within 24-48 hours after lumbar puncture | Participant-reported pain at the lumbar puncture site, measured using a numeric rating scale from 0 to 10, with higher scores indicating greater pain. |
| Incidence of Post-Dural Puncture Headache | Within 5 days after lumbar puncture | Proportion of participants who develop a post-dural puncture headache meeting International Classification of Headache Disorders, Third Edition criteria. |
| Need for Fluoroscopic-Guided Lumbar Puncture | Within 7 days after the initial bedside lumbar puncture attempt | Proportion of participants requiring subsequent fluoroscopic-guided lumbar puncture after unsuccessful completion of the initially assigned lumbar puncture procedure. |
| Hospitalization Related to Lumbar Puncture Complications | Within 1 month of lumbar puncture. | Hospitalization due to lumbar puncture-related complications, including prolonged hospitalization for inpatients or new hospital admission for outpatients. |
Countries
United States
Outcome results
None listed