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

NCT05824546 | Recruiting DMC

• 1 other identifier: uSINE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy; Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• 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%.

  First pass is defined as the first LP attempt without withdrawing the LP needle out of the skin.

  During procedure

Secondary Outcomes (4)

• Number of needle redirections using uSINE-PAMS-guided technique.

  During procedure

• Rate of traumatic LP using uSINE-PAMS-guided technique.

  1 hour after procedure

• Pain score from LP using uSINE-PAMS-guided technique.

  Immediately after procedure

• Rate of back pain that develops within 24 hours of the LP using uSINE-PAMS-guided technique.

  Approximately 24 hours after procedure

Other Outcomes (2)

• Rate of serious complications from LP using uSINE-PAMS-guided technique.

  Within 1 week of procedure

• Influence of BMI on the success or failure of the uSINE-PAMS-guided LP.

  within 1 week of procedure

Study Arms (1)

uSINE-PAMS-guided

EXPERIMENTAL

Patients will undergo LP using uSINE-PAMS-guided technique

Procedure: Intervention Arm (uSINE-PAMS-technique)

Interventions

Intervention Arm (uSINE-PAMS-technique) PROCEDURE

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.

uSINE-PAMS-guided

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for lumbar puncture as part of their clinical care
• years of age or older
• Able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Neuroscience Institute: lead
• HiCura Medical Pte Ltd: collaborator

Study Sites (1)

National Neuroscience Institute (NNI)

Singapore, Singapore

RECRUITING

Related Publications (1)

• Lin X, Lam MLC, Chuang DF, Yuen JYE, Fu L, Jun Zhi Teh V, Marliya A, Saffari SE, Lim CSJ, Wong YL, Seet YHC. uSINE-PAMS Artificial Intelligence-Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy: A Pilot Study Report. Neurol Clin Pract. 2025 Apr;15(2):e200447. doi: 10.1212/CPJ.0000000000200447. Epub 2025 Feb 25.

  PMID: 40201070 DERIVED

Central Study Contacts

Xuling Lin, MBBS

CONTACT

63577153; lin.xu.ling@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 21, 2023
• Study Start: May 26, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-04

Locations

SG (1)