uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- First pass success rate of obtaining CSF using uSINE-PAMS-guided technique against the traditional landmark-based method of 55%.technique against the traditional landmark-based method of 55%.
研究概览
简要总结
This study aims to test the effectiveness of uSINE-PAMS technology for lumbar puncture compared to traditional landmark-based technique. uSINE is a machine-learning software designed to aid the operators in ultrasound-guided lumbar puncture while PAMS is a two-part hardware to translate data from ultrasound to accurate needle insertion and angulation.
详细描述
Lumbar puncture (LP) is a routine invasive procedure performed for the diagnosis and treatment of central nervous system disorders. The traditional landmark-based method is associated with a high failure rate of up to 50%, leading to complications including back pain and epidural hematoma, diagnostic delay, and increased healthcare costs. The success rate has been improved with ultrasound guided LP but the use of ultrasound-guided LP has not been widespread due to inadequate training in ultrasound use and the inability to translate information derived from ultrasonography to the LP procedure. uSINE-PAMS was designed to address these challenges: uSINE is a machine-learning software to aid the operators in ultrasound-guided LP; PAMS is a two-part hardware to translate data from ultrasound to accurate needle insertion and angulation.
This study consists of a pilot phase to test the usability of uSINE-PAMs and allow for improvement in technology and clinical workflow for uSINE-PAMS. In the pilot phase, experienced NNI clinicians who have participated in a previous healthy volunteer study and have been trained to use uSINE will be the operators performing the uSINE-PAMS-guided lumbar puncture. During and upon completion of the study, challenges in the use of uSINE and PAMS to conduct LP as well as in the implementation of uSINE-PAMS in the clinical workflow will be determined and addressed prior to the main study, open-label single-arm phase 2 clinical trial. Ten patients will be recruited in this pilot phase.
Following the pilot phase, an open-label single-arm phase 2 clinical trial to test the effectiveness of uSINE-PAMS-guided LP against historical data of 55% from traditional landmark-based method. 50 patients who are planned for LP will be recruited to undergo LP using the uSINE-PAMS-guided technique. The overall hypothesis is that uSINE-PAMS-guided LP will achieve at least 20% improvement in first pass success rate of obtaining cerebrospinal fluid compared to historical data of 55% from traditional landmark-based technique, therefore leading to reduction in complication rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for lumbar puncture as part of their clinical care
- •21 years of age or older
- •Able to provide informed consent
排除标准
- •Allergy to ultrasound gel
- •Previous lumbar spinal instrumentation
- •Patients with suspected spinal epidural abscess or any other infection at the potential site of needle entry on the back
- •Possible raised intracranial pressure with risk of cerebral herniation, including presence of obstructive hydrocephalus, intracranial space-occupying lesion and cerebral edema
- •Presence of significant thrombocytopenia (platelet <40k) or other bleeding diathesis; patients on antiplatelet and/or anticoagulation may be included if their antiplatelet and/or anticoagulation can be and are stopped for an adequate duration prior to lumbar puncture according to the institution guidelines.
研究组 & 干预措施
uSINE-PAMS-guided
Patients will undergo LP using uSINE-PAMS-guided technique
干预措施: Intervention Arm (uSINE-PAMS-technique) (Procedure)
结局指标
主要结局
First pass success rate of obtaining CSF using uSINE-PAMS-guided technique against the traditional landmark-based method of 55%.technique against the traditional landmark-based method of 55%.
时间窗: During procedure
First pass is defined as the first LP attempt without withdrawing the LP needle out of the skin.
次要结局
- Rate of back pain that develops within 24 hours of the LP using uSINE-PAMS-guided technique.(Approximately 24 hours after procedure)
- Number of needle redirections using uSINE-PAMS-guided technique.(During procedure)
- Pain score from LP using uSINE-PAMS-guided technique.(Immediately after procedure)
- Rate of traumatic LP using uSINE-PAMS-guided technique.(1 hour after procedure)