Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19
- Conditions
- Critical Illness PolyneuromyopathyEarly MobilizationRehabilitationCovid19Critical IllnessRobotics
- Interventions
- Device: Robotic assisted early mobilization
- Registration Number
- NCT04750265
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Age ≥ 18 years
- Invasive mechanically ventilated and expected to be ventilated for another 24 hours
- Cardiovascular stability, allowing mobilization
- Respiratory stability, allowing mobilization
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic assisted early mobilization Robotic assisted early mobilization Early mobilization therapy assisted with robotics
- Primary Outcome Measures
Name Time Method Level of mobilization 5 days Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)
- Secondary Outcome Measures
Name Time Method Days of sedation during ICU stay (normally up to 30 days) Days under sedative medication during ICU stay
Mortality at 180 days after study start Mortality during ICU and Hospital stay and 180 days after admission at ICU
Functional status at 180 days after study start Measurement of ADLs/IADLs for which patients need assistance
Initiation of first Mobilization 5 days Time of first mobilization after admission on ICU (in hours)
Number of Health care provider 5 days Number of Health care provider needed for mobilization
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
Frequency of Mobilization 5 days Frequency of early mobilization during mechanical ventilation
Mobilization duration 5 days Average duration of mobilization sessions during mechanical ventilation (in min)
Muscle wasting 5 days Muscle wasting assessed using ultrasound measurement of the M. femoris
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
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
DRG workplace data Hospital stay (approx. 30 days) expenses of the hospital stay
Trial Locations
- Locations (1)
Charité - Univiversitätsmedizin Berlin
🇩🇪Berlin-Mitte, Berlin, Germany