Covid19, Critical Illness, Critical Illness Polyneuromyopathy, Early Mobilization, Rehabilitation, Robotics
Conditions
Keywords
COVID19, Early mobilization, robotics, Vemo
Brief summary
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
Interventions
DEVICERobotic assisted early mobilization
Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
Sponsors
Reactive Robotics GmbH
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled, parallel-group, open label pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Invasive mechanically ventilated and expected to be ventilated for another 24 hours * Cardiovascular stability, allowing mobilization * Respiratory stability, allowing mobilization
Exclusion criteria
* Bed-bound before ICU admission * Bed-rest order or contraindication of weight load of the lower extremity or spine * Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis * Fresh SAB, ICB or elevated ICP * Status epilepticus * Acute intoxication * Shock with catecholamine doses \>0.3μg/kg/min or acute bleeding including organ ruptures * Multiorgan failure with lactate \> 4 mmol/l * Body height outside the range 150-195 cm * Body weight outside the range 45-135 kg * pAVK IV° * Pacemakers or other electrical stimulators * Implanted medical pumps * Pregnancy * Life expectancy below 7 days or acute palliative care situation * Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request * Unable to understand the official language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of mobilization | 5 days | Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Mobilization | 5 days | Frequency of early mobilization during mechanical ventilation |
| Initiation of first Mobilization | 5 days | Time of first mobilization after admission on ICU (in hours) |
| Mobilization duration | 5 days | Average duration of mobilization sessions during mechanical ventilation (in min) |
| Depth of sedation | 5 days | Depth of sedation measured with RASS during the first 5 days after admission on ICU |
| Days of mechanical ventilation | during ICU stay (normally up to 30 days) | Days of mechanical ventilation during ICU stay |
| Days of Intubation | during ICU stay (normally up to 30 days) | Days of Intubation during ICU stay |
| Days of Delirium | during ICU stay (normally up to 30 days) | Days of Delirium during ICU stay |
| MRC Score | One time point before ICU Discharge | MRC Score at ICU Discharge |
| Days of sedation | during ICU stay (normally up to 30 days) | Days under sedative medication during ICU stay |
| Number of Health care provider | 5 days | Number of Health care provider needed for mobilization |
| Mortality | at 180 days after study start | Mortality during ICU and Hospital stay and 180 days after admission at ICU |
| Length of stay | Hospital stay (approx. 30 days) | Length of stay at ICU , in Hospital (in days) |
| Global function | at 180 days after study start | Global function measured with WHODAS |
| Health care provider assessment | 5 days | Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5) |
| Safety events | 5 days after study start | Frequency of safety events during mobilization |
| Functional status | at 180 days after study start | Measurement of ADLs/IADLs for which patients need assistance |
| DRG workplace data | Hospital stay (approx. 30 days) | expenses of the hospital stay |
| Muscle wasting | 5 days | Muscle wasting assessed using ultrasound measurement of the M. femoris |
Countries
Germany
Outcome results
None listed