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RECRUITING
NCT05824546
NA

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

Sponsor: National Neuroscience Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - 105 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-05-26

Completion Date

2024-07-31

Last Updated

2024-05-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

National Neuroscience Institute (NNI)

Singapore, Singapore