Ultrasound-assisted vs. Standard Palpation Technique for Lumbar Puncture in Adults: A Randomized Controlled Trial of Procedural Success, Efficiency, and Complications
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- First Attempt Lumbar Puncture Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ultrasound-Assisted Lumbar Puncture (Procedure)
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.
干预措施: Standard Palpation-Guided Lumbar Puncture (Other)
结局指标
主要结局
First Attempt Lumbar Puncture Success
时间窗: 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.
次要结局
- Overall Lumbar Puncture Success(During the initial lumbar puncture encounter)
- Number of Needle Reinsertions(During the lumbar puncture procedure)
- Number of Needle Redirections(During the lumbar puncture procedure)
- Procedure Time(During the lumbar puncture procedure)
- Time to CSF Return(During the lumbar puncture process)
- Incidence of Traumatic Tap(During the lumbar puncture procedure)
- Incidence of Radicular Pain During Lumbar Puncture(During the lumbar puncture procedure)
- Post-Procedural Back Pain(Within 24-48 hours after lumbar puncture)
- Incidence of Post-Dural Puncture Headache(Within 5 days after lumbar puncture)
- Need for Fluoroscopic-Guided Lumbar Puncture(Within 7 days after the initial bedside lumbar puncture attempt)
- Hospitalization Related to Lumbar Puncture Complications(Within 1 month of lumbar puncture.)
研究者
Swarna Rajagopalan
Associate Professor of Neurology, Attending Physician, Neurocritical Care, Principal Investigator
The Cooper Health System