usine-pams artificial intelligence driven, ultrasound-guided lumbar puncture to improve procedural accuracy

Conditions: Ultrasound Therapy; Lumbar Puncture

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * patients planned for lumbar puncture as part of their clinical care * 21 years of age or older * able to provide informed consent exclusion criteria: * 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.