uSINE-PAMS Artificial Intelligence Driven, Ultrasound-Guided Lumbar Puncture to Improve Procedural Accuracy
National Neuroscience Institute
50 participants
May 26, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Patients planned for lumbar puncture as part of their clinical care
- years of age or older
- Able to provide informed consent
Exclusion Criteria5
- 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.
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Interventions
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)
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NCT05824546