Critical Illness
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTBody Impedance Analysis
Body Impedance Analysis
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation: Skeletal muscle mass and MRC-Score | till Day 30 | The primary endpoint is the correlation between Skeletal muscle mass (SMM) measured by BIA and MRC score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UCR : MRC correlation | till Day 30 | Correlation of urea-creatinine ratio in blood with MRC score. |
| Kreatinin : MRC correlation | till Day 30 | Correlation of creatinine in blood with MRC score. |
| IMS during the ICU stay | till Day 30 or ICU discharge | achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS) |
| ICU mortality | till Day 30 | Mortality during ICU stay |
| Correlation CSA and Skeletal muscle mass | till Day 30 | Cross sectional area of muscle ultrasound (M. rectus femoris) and Skeletal muscle mass (SMM) measured by BIA |
| Hospital mortality | till Day 30 | Mortality during Hospital stay |
| ICU-LOS | till Day 30 (till ICU discharge) | Length of stay in the ICU |
| Hospital LOS | till Day 30 (till hospital discharge) | Length of stay in the hospital |
| in-hospital mortality | till Day 30 (till hospital discharge) | Mortality during the Hospital stay |
| Duration of Mechanical ventilation | till Day 30 | Duration of invasive mechanical ventilator dependency |
Countries
Germany
Outcome results
None listed