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

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.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound Therapy; Lumbar Puncture
• Intervention / Treatment: Procedure: Intervention Arm (uSINE-PAMS technique):; Procedure: Control Arm (traditional landmark-based technique):

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, 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuling Lin, MBBS; Phone Number: 63577153; Email: lin.xu.ling@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National Neuroscience Institute (NNI)
    • Contact: Xuling Lin, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 <100k) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Arm; Patients will undergo LP using uSINE-PAMS-guided technique	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.
Active Comparator: Control Arm; Patients will undergo LP using traditional landmark-based method	Procedure: Control Arm (traditional landmark-based 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 similarly identified by palpation of external landmarks of iliac crests and spinous process of lumbar vertebrae L3, L4 and L5. Markings on the patients' skin surface will be made with a washable marker or any other methods according to the operator's preference to enable relocation of the site 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 into marked entry site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the first pass success rate of obtaining cerebrospinal fluid using uSINE-PAMS-guided technique against the traditional landmark-based method	First pass is defined as the first LP attempt without withdrawing the LP needle out of the skin.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the number of needle redirections using uSINE-PAMS-guided technique with that using the traditional landmark-based method	Needle redirection is defined as the number of times the LP needle was repositioned to obtain the CSF without withdrawing out of the skin.	During procedure
To compare the rate of traumatic LP using uSINE-PAMS-guided technique against the traditional landmark-based method	Traumatic LP is defined as needle-induced blood (>5 red blood cells/ul) in the cerebrospinal fluid; Cases where red blood cells are expected in the cerebrospinal fluid will be excluded from this analysis.	1 hour after procedure
To compare the pain score from LP using uSINE-PAMS-guided technique with that from LP using the traditional landmark-based method	Pain score will be assessed using the Universal Pain Assessment Tool which has a scale of 0-10.	Immediately after procedure
To compare the rate of back pain that develops within 24 hours of the LP using uSINE-PAMS-guided technique with the traditional landmark-based method	Pain score will be assessed using the Universal Pain Assessment Tool which has a scale of 0-10.	Approximately 24 hours after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the rate of serious complications from LP using uSINE-PAMS-guided technique with that from LP using the traditional landmark-based method	Serious complications include spinal hematoma, subdural hematoma, central nervous system infection and headaches requiring hospitalizations	Within 1 week of procedure

Collaborators and Investigators

• Sponsor: National Neuroscience Institute
• Collaborators: HiCura Medical Pte Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: uSINE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No