Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19

Study Overview
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Brief Summary
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Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.

Official Title
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Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)

Conditions
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Covid19, Critical Illness, Critical Illness Polyneuromyopathy, Early Mobilization, Rehabilitation, Robotics

Intervention / Treatment
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* Device: Robotic assisted early mobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, parallel-group, open label pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic assisted early mobilization<br>Early mobilization therapy assisted with robotics | Device: Robotic assisted early mobilization<br>* Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.<br>|
| No Intervention: Standard Care<br>Mobilization according to standard care by staff | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Early mobilization, robotics, Vemo