search
Back to results

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

Primary Purpose

Ultrasound Therapy, Lumbar Puncture

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Intervention Arm (uSINE-PAMS technique):
Control Arm (traditional landmark-based technique):
Sponsored by
National Neuroscience Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ultrasound Therapy

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Neuroscience Institute (NNI)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

Patients will undergo LP using uSINE-PAMS-guided technique

Patients will undergo LP using traditional landmark-based method

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 22, 2023
Last Updated
June 20, 2023
Sponsor
National Neuroscience Institute
Collaborators
HiCura Medical Pte Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05824546
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Neuroscience Institute
Collaborators
HiCura Medical Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Therapy, Lumbar Puncture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Active Comparator
Arm Description
Patients will undergo LP using uSINE-PAMS-guided technique
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Patients will undergo LP using traditional landmark-based method
Intervention Type
Procedure
Intervention Name(s)
Intervention Arm (uSINE-PAMS technique):
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control Arm (traditional landmark-based technique):
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare the first pass success rate of obtaining cerebrospinal fluid using uSINE-PAMS-guided technique against the traditional landmark-based method
Description
First pass is defined as the first LP attempt without withdrawing the LP needle out of the skin.
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
To compare the number of needle redirections using uSINE-PAMS-guided technique with that using the traditional landmark-based method
Description
Needle redirection is defined as the number of times the LP needle was repositioned to obtain the CSF without withdrawing out of the skin.
Time Frame
During procedure
Title
To compare the rate of traumatic LP using uSINE-PAMS-guided technique against the traditional landmark-based method
Description
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.
Time Frame
1 hour after procedure
Title
To compare the pain score from LP using uSINE-PAMS-guided technique with that from LP using the traditional landmark-based method
Description
Pain score will be assessed using the Universal Pain Assessment Tool which has a scale of 0-10.
Time Frame
Immediately after procedure
Title
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
Description
Pain score will be assessed using the Universal Pain Assessment Tool which has a scale of 0-10.
Time Frame
Approximately 24 hours after procedure
Other Pre-specified Outcome Measures:
Title
To compare the rate of serious complications from LP using uSINE-PAMS-guided technique with that from LP using the traditional landmark-based method
Description
Serious complications include spinal hematoma, subdural hematoma, central nervous system infection and headaches requiring hospitalizations
Time Frame
Within 1 week of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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 <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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuling Lin, MBBS
Phone
63577153
Email
lin.xu.ling@singhealth.com.sg
Facility Information:
Facility Name
National Neuroscience Institute (NNI)
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuling Lin, MBBS

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs