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Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients (RAIMUS)

Primary Purpose

Tetanus

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Real-time AI-assisted muscle ultrasound
Sponsored by
Oxford University Clinical Research Unit, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tetanus focused on measuring Muscle Wasting, Intensive Care Unit, Muscle ultrasound, Artificial Intelligence, Deep Learning

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥16 years Written informed consent Staff and equipment available for ultrasound Admitted to Viet Anh Ward ICU with a diagnosis of meningitis or encephalitis or Ablett Grade 3 or 4 tetanus Within 72 hours of ICU admission Duration of ICU stay expected at least 5 days Exclusion Criteria: Informed consent not given Contraindication to ultrasound scan

Sites / Locations

  • Hospital for Tropical Diseases at Ho Chi Minh cityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Real-time AI-assisted muscle ultrasound

Manual muscle ultrasound

Arm Description

RAIMUS software provides automatic segmentation and size measurement for the RFCSA

Manual segmentation and size measurement for the RFCSA

Outcomes

Primary Outcome Measures

Reproducibility of RFCSA measurements
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will compare the reliability and agreement metrics of the RF measurement

Secondary Outcome Measures

Time spent on ultrasound examination
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will record the time needed to carry out the muscle ultrasound examinations

Full Information

First Posted
August 30, 2023
Last Updated
September 10, 2023
Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT06034093
Brief Title
Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients
Acronym
RAIMUS
Official Title
Real-time AI-assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in Intensive Care Unit Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxford University Clinical Research Unit, Vietnam
Collaborators
King's College London

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 investigate the feasibility of using a real-time artificial intelligent (AI)-assisted tool for Rectus Femoris cross sectional area measurement from muscle ultrasound to improve reliability, reduce inter- and intra-observer variability and reduce operator time spent on ultrasound examination
Detailed Description
This project proposes to develop computational methods to automatically analyze conventional 2D muscle ultrasound images in real time to assist operators circumvent achieve high quality reproducible views and measurements specifically for Rectus Femoris muscle. Study design: This is a prospective observational study to test the reliability of AI-assisted muscle ultrasound at the patient's bedside compared to standard RFCSA ultrasound. All measurements will be performed in adult patients with severe tetanus (Ablett Grade 3 or 4) admitted to the Adult ICU at HTD expected to stay at least 5 days. All patients are on mechanical ventilation, muscle relaxation and neuromuscular blockers following the Ministry of Health guidelines. Study procedures: Three ultrasound examinations will be carried out according to a standard operating procedure where patients are in the supine position with the leg in neutral rotation. Measurements will be taken using 12L-RS linear probe, Venue Go ultrasound machine (General Electric Healthcare, London, UK). Statistical analysis: Study will compare the intra- and interobserver variability of measurements and examination duration. All statistical analysis was performed with R version 4.0.4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus
Keywords
Muscle Wasting, Intensive Care Unit, Muscle ultrasound, Artificial Intelligence, Deep Learning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The developed AI assistant, named RAIMUS, was deployed in real-time using the PRETUS tool. The ultrasound machine HDMI output was connected to the laptop via a USB framegrabber. This allowed the user to use an external screen with an AI overlay instead of the screen of the ultrasound machine. The interface to RAIMUS is as follows. On the right of the screen, there is a widget containing information from the automatic muscle segmentation, including the muscle delineation continuously overlaid onto the ultrasound image and the corresponding cross-sectional area in cm2. The segmentation overlay and related information can be enabled or disabled by the user.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real-time AI-assisted muscle ultrasound
Arm Type
Experimental
Arm Description
RAIMUS software provides automatic segmentation and size measurement for the RFCSA
Arm Title
Manual muscle ultrasound
Arm Type
No Intervention
Arm Description
Manual segmentation and size measurement for the RFCSA
Intervention Type
Device
Intervention Name(s)
Real-time AI-assisted muscle ultrasound
Intervention Description
RAIMUS software provides automatic segmentation and size measurement for the RFCSA
Primary Outcome Measure Information:
Title
Reproducibility of RFCSA measurements
Description
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will compare the reliability and agreement metrics of the RF measurement
Time Frame
during the study procedure
Secondary Outcome Measure Information:
Title
Time spent on ultrasound examination
Description
In this trial, the users are randomly assigned to scan muscle ultrasound with and without AI-assisted software to measure the size of the Rectus Femoris muscle. The investigators will record the time needed to carry out the muscle ultrasound examinations
Time Frame
during the study procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥16 years Written informed consent Staff and equipment available for ultrasound Admitted to Viet Anh Ward ICU with a diagnosis of meningitis or encephalitis or Ablett Grade 3 or 4 tetanus Within 72 hours of ICU admission Duration of ICU stay expected at least 5 days Exclusion Criteria: Informed consent not given Contraindication to ultrasound scan
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nhat TH Phung, BSc
Phone
+84347900911
Email
nhatpth@oucru.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Yacoub, PhD
Organizational Affiliation
Oxford University Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Tropical Diseases at Ho Chi Minh city
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nhat
First Name & Middle Initial & Last Name & Degree
Nhat TH Phung, BSc
First Name & Middle Initial & Last Name & Degree
Louise Thwaites, PhD
First Name & Middle Initial & Last Name & Degree
Sophie Yacoub, PhD
First Name & Middle Initial & Last Name & Degree
Hao V Nguyen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Real-time Artificial Intelligent (AI)-Assisted Muscle Ultrasound for Monitoring Muscle Mass Reduction in ICU Patients

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