uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy

Ultrasound Therapy Clinical Trial

Official title: uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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, a randomized controlled trial. Ten patients will be recruited in this pilot phase. Following the pilot phase, the main study (randomized controlled trial) will be conducted to evaluate the effectiveness of uSINE-PAMS-guided lumbar puncture. 100 patients will be randomized to undergo LP using uSINE-PAMS guided technique or traditional landmark-based method. The investigators hypothesize that uSINE-PAMS guided lumbar puncture will achieve at least 20% improvement in first pass success rate of obtaining cerebrospinal fluid compared to traditional landmark-based technique, therefore leading to reduction in complication rates. ;

Related Conditions & MeSH terms

• Lumbar Puncture
• Ultrasound Therapy
• Wounds and Injuries

• NCT number: NCT05824546
• Study type: Interventional
• Source: National Neuroscience Institute
• Contact: Xuling Lin, MBBS
• Phone: 63577153
• Email: lin.xu.ling@singhealth.com.sg
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Completion date: March 31, 2024