AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness

NCT06765551 | Recruiting

• 1 other identifier: 2024-3434-BO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational case-control study is to investigate, whether artificial intelligence can detect ultrasound-derived imaging characteristics typical for intensive care unit-acquired weakness. The main questions it aims to answer are:

1. 1.Is the evaluation of specific parameters of neuromuscular ultrasound using AI-based image analysis suitable for detecting and monitoring critically ill ICU patients with ICUAW?
2. 2.Do the results of AI-based ultrasound image analysis correlate with:

Conditions

Intensive Care Unit-acquired Weakness; Artifical Intelligence; Ultrasound

Keywords

weakness; neuromuscular; critical illness polyneuropathy; critical illness myopathy; neuromuscular impairment

Outcome Measures

Primary Outcomes (1)

• Incidence of abnormalities of muscle echogenicity assesed by muscular ultrasound

  Determination of the number of patients correctly classified as ICUAW (+) using AI-based ultrasound evaluation

  Day 14

Secondary Outcomes (11)

• Incidence of ICUAW severity assessed by Heckmatt Scale

  Day 14

• Incidence of ICUAW severity assessed by Medical Research Council Sum Score

  Day 14

• Days on ventilation

  Day 30

• Days on vasopressors

  Day 30

• Number of days in Hospital

  Day 30

Study Arms (3)

Patients with ICUAW (ICUAW+)

Critically ill patients with ICUAW.

Diagnostic Test: Neuromuscular Ultrasound

Patients without ICUAW (ICUAW-)

Critically ill patients without ICUAW.

Diagnostic Test: Neuromuscular Ultrasound

Healthy controls without ICUAW (ICUAW-)

Diagnostic Test: Neuromuscular Ultrasound

Interventions

Neuromuscular Ultrasound DIAGNOSTIC_TEST

Non-invasive ultrasound of peripheral muscles of the upper and lower extremities with additional artificiall intelligence processing of ultrasound images.

Healthy controls without ICUAW (ICUAW-); Patients with ICUAW (ICUAW+); Patients without ICUAW (ICUAW-)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with critical illness fulfilling the inclusion criteria should be screened for the study on two surgical ICUs at the department of anesthesiology and intensive care medicine of Jena University Hospital, Germany.

You may qualify if:

• Patients aged 18 years or above
• Major elective surgery, e.g. cardiothoracic or abdominal surgery
• Expected ICU stay \>1 day postoperatively
• Healthy, age-machted subjects without ICUAW (recruited from staff of the department of anesthesiology and intensive care medicine)

You may not qualify if:

• No informed consent
• Emergency surgery
• Previous participation in the same study
• Preexisting neuromuscular disease
• Preexisting central nervous system disease with residual neuromuscular impairment (e.g. cerebral haemorrhage, stroke, brain tumor)
• High-dose glucocorticoid therapy (\>300 mg hydrocortisone or equivalent per day) before or during particiation in the study

Sponsors & Collaborators

• Jena University Hospital: lead
• University of Rostock: collaborator

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

Jena, Thuringia, 07747, Germany

RECRUITING

MeSH Terms

Conditions

Asthenia; Polyneuropathies

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• PD Dr. Johannes Ehler, M.D.

  Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PD Dr. Johannes Ehler, M.D.

CONTACT

+4936419323397; johannes.ehler@med.uni-jena.de

Dr. Konstantin Schubert, M.D.

CONTACT

+4936419323371; konstantin.schubert@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)