Body Impedance Analysis to Detect ICUAW

Study Overview
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Brief Summary
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The aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the Medical Research Council (MRC) score. An MRC score ≤ 48 is defined as a diagnosis of ICU acquired weakness. The correlation of the values detected by BIA and their transfer to an MRC Score ≤ 48 will be investigated. The knowledge gained will be used for early detection of ICUAW in order to reduce the consequences of the same.

Detailed Description
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Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of neuromuscular organ dysfunction. It develops in approximately 40% of all ICU patients, which corresponds to at least 1.2 million patients annually in Germany. All these patients face a wide spectrum of sequelae and increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is early severe muscle atrophy, which is as high as 17% in the first days after ICU admission. ICUAW is currently diagnosed by the MRC score, which is assessed by the sum of manual muscle strength test results in 12 muscle groups (sum score). Manual muscle testing (MMT) is not possible during the early phase in critical illness in most patients due to coma, delirium, and/or injury. In addition, there is a possible discrepancy by different observers. As a result, early detection of ICUAW may be inadequate in most patients and unreliable during critical illness. Measurement by BIA is reproducible, so differences in measurement can be attributed to changes in clinical condition. Body impedance analysis thus demonstrates a means of objective measurement. Thus, the study aims to counteract the long-term consequences of ICUAW through early detection of ICUAW by allowing countermeasures to be taken earlier.

Official Title
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Body Impedance Analysis to Detect Muscle Strength Associated With ICU Acquired Weakness

Conditions
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Critical Illness

Intervention / Treatment
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* Diagnostic Test: Body Impedance Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients aged ≥ 18 years with ventilatory support within 36 hours from ICU admission. Exclusion Criteria: With a language barrier Patients with pacemaker or other electronic implant Expected death or discontinuation of life-sustaining measures. Not walking independently before hospitalization (gait aids allowed) Allergy to electrode gel BIA or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br> | Diagnostic Test: Body Impedance Analysis<br>* Body Impedance Analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation: Skeletal muscle mass and MRC-Score | The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score. | till Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation CSA and Skeletal muscle mass | Cross sectional area of muscle ultrasound (M. rectus femoris) and Skeletal muscle mass (SMM) measured by BIA | till Day 30 | 
| UCR : MRC correlation | Correlation of urea-creatinine ratio in blood with MRC score. | till Day 30 | 
| Kreatinin : MRC correlation | Correlation of creatinine in blood with MRC score. | till Day 30 | 
| IMS during the ICU stay | achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS) | till Day 30 or ICU discharge | 
| ICU mortality | Mortality during ICU stay | till Day 30 | 
| Duration of Mechanical ventilation | Duration of invasive mechanical ventilator dependency | till Day 30 | 
| Hospital mortality | Mortality during Hospital stay | till Day 30 | 
| ICU-LOS | Length of stay in the ICU | till Day 30 (till ICU discharge) | 
| Hospital LOS | Length of stay in the hospital | till Day 30 (till hospital discharge) | 
| in-hospital mortality | Mortality during the Hospital stay | till Day 30 (till hospital discharge) |