Health TrialsbyHealthPanel

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

ConditionsIntensive Care Unit-acquired WeaknessArtifical IntelligenceUltrasound
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJena University Hospital

About this trial

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. 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. Do the results of AI-based ultrasound image analysis correlate with:

(A) the severity of ICUAW (B) the visual grading of muscle echogenicity (C) the 30- and 90-day-outcome?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

No informed consent

Emergency surgery

Previous participation in the same study

Preexisting neuromuscular disease

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Neuromuscular Ultrasound

    Diagnostic test

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

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Patients with ICUAW (ICUAW+)1 intervention
Group B: Patients without ICUAW (ICUAW-)1 intervention
Group C: Healthy controls without ICUAW (ICUAW-)1 intervention

Trial outcomes

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

Time frame
Day 14

Secondary outcomes

1

Incidence of ICUAW severity assessed by Heckmatt Scale

Time frame
Day 14
2

Incidence of ICUAW severity assessed by Medical Research Council Sum Score

Time frame
Day 14
3

Days on ventilation

Time frame
Day 30
4

Days on vasopressors

Time frame
Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jena University Hospital

Lead sponsor

University of Rostock

Collaborator

Source ClinicalTrials.gov
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