NCT05824546

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Neuroscience Institute · Academic / Other
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, 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.

Conditions

• Ultrasound Therapy
• Lumbar Puncture

Interventions

Type	Name	Description
PROCEDURE	Intervention Arm (uSINE-PAMS-technique)	Patients will be lying in a lateral recumbent position and in a fetal position with the neck, back and limbs held in flexion. L3-L4 inter-vertebral space will be identified by palpation of external landmarks of the patients' iliac crests and spinous process of lumbar vertebrae L3, L4 and L5 and confirmed using uSINE-integrated ultrasound. The angle of needle during needle advancement will also be determined using the uSINE-integrated ultrasound. Markings on the patients' skin surface will be made using PAMS (non-sterile component) to enable relocation of the site and angle of the needle entry. Patients' back will be cleaned and draped using aseptic technique. Next, local anaesthesia is infiltrated into the previously identified needle entry site before the LP needle is inserted with location and angulation according to PAMS (sterile component) guidance.

Timeline

• Start date: 2023-05-26
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-04-21
• Last updated: 2024-05-16

Locations

1 site across 1 country: Singapore