Clinical trial NCT04750265: Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19
Official title: Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Critical Illness
Critical Illness Polyneuromyopathy
Early Mobilization
Rehabilitation
Robotics
Keywords: COVID19
Early mobilization
robotics
Vemo
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Reactive Robotics GmbH
First posted: 2021-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, parallel-group, open label pilot trial
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Level of mobilization
timeFrame: 5 days
measure: Level of mobilization
timeFrame: 5 days
Secondary outcomes:
measure: Frequency of Mobilization
timeFrame: 5 days
measure: Initiation of first Mobilization
timeFrame: 5 days
measure: Mobilization duration
timeFrame: 5 days
measure: Depth of sedation
timeFrame: 5 days
measure: Days of sedation
timeFrame: during ICU stay (normally up to 30 days)
measure: Days of mechanical ventilation
timeFrame: during ICU stay (normally up to 30 days)
measure: Days of Intubation
timeFrame: during ICU stay (normally up to 30 days)
measure: Days of Delirium
timeFrame: during ICU stay (normally up to 30 days)
measure: MRC Score
timeFrame: One time point before ICU Discharge
measure: Muscle wasting
timeFrame: 5 days
measure: Number of Health care provider
timeFrame: 5 days
measure: Mortality
timeFrame: at 180 days after study start
measure: Length of stay
timeFrame: Hospital stay (approx. 30 days)
measure: Global function
timeFrame: at 180 days after study start
measure: Health care provider assessment
timeFrame: 5 days
measure: Safety events
timeFrame: 5 days after study start
measure: Functional status
timeFrame: at 180 days after study start
measure: DRG workplace data
timeFrame: Hospital stay (approx. 30 days)
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Charité - Univiversitätsmedizin Berlin
state: Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
References: