Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19
Study Details
Study Description
Brief Summary
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Robotic assisted early mobilization Early mobilization therapy assisted with robotics |
Device: Robotic assisted early mobilization
Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
|
| No Intervention: Standard Care Mobilization according to standard care by staff |
Outcome Measures
Primary Outcome Measures
- 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)
- 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
- 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 sedation [during ICU stay (normally up to 30 days)]
Days under sedative medication during ICU stay
- 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
- Muscle wasting [5 days]
Muscle wasting assessed using ultrasound measurement of the M. femoris
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years
-
Invasive mechanically ventilated and expected to be ventilated for another 24 hours
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Cardiovascular stability, allowing mobilization
-
Respiratory stability, allowing mobilization
Exclusion Criteria:
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Bed-bound before ICU admission
-
Bed-rest order or contraindication of weight load of the lower extremity or spine
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Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
-
Fresh SAB, ICB or elevated ICP
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Status epilepticus
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Acute intoxication
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Shock with catecholamine doses >0.3μg/kg/min or acute bleeding including organ ruptures
-
Multiorgan failure with lactate > 4 mmol/l
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Body height outside the range 150-195 cm
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Body weight outside the range 45-135 kg
-
pAVK IV°
-
Pacemakers or other electrical stimulators
-
Implanted medical pumps
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité - Univiversitätsmedizin Berlin | Berlin-Mitte | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- Reactive Robotics GmbH
Investigators
- Principal Investigator: Stefan J Schaller, MD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ROBEM II