Status:
COMPLETED
Robotic Assisted Early Mobilization in Ventilated ICU Patients
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Reactive Robotics GmbH
Conditions:
Critical Illness Polyneuromyopathy
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Invasive mechanically ventilated and expected to be ventilated for another 24 hours
- Cardiovascular stability, allowing mobilization
- Respiratory stability, allowing mobilization
Exclusion
- 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
- ICU stay \> 72h at the time of enrolment
- Translated with www.DeepL.com/Translator (free version)
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04423796
Start Date
November 13 2020
End Date
September 12 2022
Last Update
September 8 2023
Active Locations (1)
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1
Charité - Univiversitätsmedizin Berlin
Mitte, State of Berlin, Germany, 10117