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

National Neuroscience Institute

Status

Enrolling

Conditions

Ultrasound Therapy

Lumbar Puncture

Treatments

Procedure: Intervention Arm (uSINE-PAMS-technique)

Study type

Interventional

Funder types

Other

Identifiers

NCT05824546

uSINE

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

21 to 105 years old

Volunteers

No Healthy Volunteers

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.