Clinical trial NCT05824546: uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
Official title: uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound Therapy
Lumbar Puncture
Lead sponsor: National Neuroscience Institute
Sponsor class: OTHER
Collaborators: name: HiCura Medical Pte Ltd
First posted: 2023-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: 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%.
timeFrame: During procedure
Secondary outcomes:
measure: Number of needle redirections using uSINE-PAMS-guided technique.
timeFrame: During procedure
measure: Rate of traumatic LP using uSINE-PAMS-guided technique.
timeFrame: 1 hour after procedure
measure: Pain score from LP using uSINE-PAMS-guided technique.
timeFrame: Immediately after procedure
measure: Rate of back pain that develops within 24 hours of the LP using uSINE-PAMS-guided technique.
timeFrame: Approximately 24 hours after procedure
Other outcomes:
measure: Rate of serious complications from LP using uSINE-PAMS-guided technique.
timeFrame: Within 1 week of procedure
measure: Influence of BMI on the success or failure of the uSINE-PAMS-guided LP.
timeFrame: within 1 week of procedure
Locations:
city: Singapore
country: Singapore
facility: National Neuroscience Institute (NNI)
Study officials:
References: