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| Name | Class |
|---|---|
| Reactive Robotics GmbH | UNKNOWN |
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Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic assisted early mobilization | Experimental | Early mobilization therapy assisted with robotics |
|
| Standard Care | No Intervention | Mobilization according to standard care by staff |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted early mobilization | Device | Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of mobilization | Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10) | 5 days |
| Level of mobilization | Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Mobilization | Frequency of early mobilization during mechanical ventilation | 5 days |
| Initiation of first Mobilization | Time of first mobilization after admission on ICU (in hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan J Schaller, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Univiversitätsmedizin Berlin | Mitte | State of Berlin | 10117 | Germany |
Depersonalized data can be requested from the PI after publication of the study for scientific purpose.
After publishing results.
Data will be shared to other researchers on reasonable request.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Randomized, controlled, parallel-group, open label pilot trial
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| 5 days |
| Mobilization duration | Average duration of mobilization sessions during mechanical ventilation (in min) | 5 days |
| Depth of sedation | Depth of sedation measured with RASS during the first 5 days after admission on ICU | 5 days |
| Days of sedation | Days under sedative medication during ICU stay | during ICU stay (normally up to 30 days) |
| Days of mechanical ventilation | Days of mechanical ventilation during ICU stay | during ICU stay (normally up to 30 days) |
| Days of Intubation | Days of Intubation during ICU stay | during ICU stay (normally up to 30 days) |
| Days of Delirium | Days of Delirium during ICU stay | during ICU stay (normally up to 30 days) |
| MRC Score | MRC Score at ICU Discharge | One time point before ICU Discharge |
| Muscle wasting | Muscle wasting assessed using ultrasound measurement of the M. femoris | 5 days |
| Number of Health care provider | Number of Health care provider needed for mobilization | 5 days |
| Mortality | Mortality during ICU and Hospital stay and 180 days after admission at ICU | at 180 days after study start |
| Length of stay | Length of stay at ICU , in Hospital (in days) | Hospital stay (approx. 30 days) |
| Global function | Global function measured with WHODAS | at 180 days after study start |
| Health care provider assessment | Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5) | 5 days |
| Safety events | Frequency of safety events during mobilization | 5 days after study start |
| Functional status | Measurement of ADLs/IADLs for which patients need assistance | at 180 days after study start |
| DRG workplace data | expenses of the hospital stay | Hospital stay (approx. 30 days) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |