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| Name | Class |
|---|---|
| European Society of Intensive Care Medicine | OTHER |
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Rehabilitation already begins in the intensive care unit (ICU) to maintain or restore the functional capacity of ICU patients and to counteract the long-term effects of intensive care treatment. Mobilisation is an important component.
The aim of this multinational observational study is to record and evaluate the different mobilisation practices for ICU patients worldwide. The investigators want to find out which forms of mobilisation in intensive care patients achieve the best results in terms of physical function, functional status and quality of life.
The goal is to recruit over 6,000 patients internationally. No interventions will be carried out, only routine clinical data will be documented and standardised and already established physical tests and questionnaires will be used.
Intensive care treatment can have long-term effects on patients. Around 40% of intensive care unit (ICU) patients develop an Intensive Care Unit Acquired Weakness (ICUAW), which leads to functional limitations and an impairment of independence, participation in everyday life, quality of life and ability to work. Recent studies have shown that early mobilisation has a positive effect on the course of the disease, including improved physical function and independence, shorter ventilation times, and shorter ICU and hospital stays. However, there is currently no standardised approach to mobilisation and the dosage required to achieve the best health outcomes in ICU patients is unknown. There is also a lack of data on patients who were functionally dependent before hospital admission and on patients who were not on invasive mechanical ventilation.
The main objectives of the observational study are:
The investigators aim to recruit over 6,000 patients internationally from a minimum of 200 intensive care units. The total duration of the study is 21 months, with participation per patients being 90 days. Routine clinical data and mobilisation data from ICU will be documented, and standardised functional tests and questionnaires will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Independent | Patients who have been functionally independent before ICU admission | ||
| Dependent | Patients who have been functionally dependent before ICU admissoin |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical function at ICU discharge | Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function. | ICU discharge (up to Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Highest level of mobility at ICU discharge and 90 days | Highest level of mobility measured with the ICU Mobility Scale (IMS). The scale ranges from 0 to 10, with higher scores indicating a higher level of mobility (up to independent walking). | ICU discharge (up to Day 28) and Day 90 |
| Physical function at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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Intensive care unit patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vera Karner, MSc | Contact | +4314040041020 | erupt@muv.ac.at | |
| Stefan J Schaller, MD | Contact | +4314040041020 | aai-research@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Stefan J Schaller, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | State of Vienna | 1090 | Austria |
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| Label | URL |
|---|---|
| Study Webpage English | View source |
| Study Webpage German | View source |
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Priority will have requests from within the study group. Other requests for research purposes will be reviewed and have to sign contract including data protection.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function. |
| Day 90 |
| Frailty/ Functional status at ICU discharge and 90 days | Frailty/ Functional status measured with the Clinical Frailty Scale (CFS). The scale ranges from 1 (very fit) to 9 (terminally ill), with higher scores indicating a higher degree of frailty. | ICU discharge (up to Day 28) and Day 90 |
| ICU LOS | Length of stay in the ICU | ICU admission until ICU discharge (up to Day 28) |
| Hospital LOS | Length of stay in the hospital | ICU admission until hospital discharge |
| ICU mortality | Mortality during ICU stay | ICU admission until ICU discharge (up to Day 28) |
| Hospital mortality | Mortality during hospital stay | ICU admission until hospital discharge |
| 90-day mortality | Mortality at day 90 | Day 90 |
| Disability at 90 days | Disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item version). Each item is rated on a scale from 1 (no difficulty) to 5 (extreme or cannot do), with higher scores indicating greater disability. | Day 90 |
| Activities of Daily Living (ADLs) at ICU discharge and 90 days | Activities of Daily Living (ADLs) measured with the Barthel Score. The total score ranges from 0 to 100, with higher scores indicating less assistance and greater independence in performing ADLs. | ICU discharge (up to Day 28) and Day 90 |