Clinical trial NCT04423796: Robotic Assisted Early Mobilization in Ventilated ICU Patients
Official title: Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness Polyneuromyopathy
Critical Illness
Early Ambulation
Rehabilitation
Keywords: Early mobilization
pilot trial
feasibility trial
robotic assisted
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Reactive Robotics GmbH
First posted: 2020-06-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
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 robotic assisted early mobilization vs. early mobilization in critically ill patients.


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
* ICU stay \> 72h at the time of enrolment

Translated with www.DeepL.com/Translator (free version)

Primary outcomes:
measure: Feasibility of early mobilization
timeFrame: Up to Day 5
Secondary outcomes:
measure: Mobilization level
timeFrame: up to Day 5
measure: Mobilization duration
timeFrame: up to Day 5
measure: Frequency of mobilization
timeFrame: up to Day 5
measure: Pain level
timeFrame: up to Day 5
measure: Anxiety
timeFrame: up to Day 5
measure: Patient satisfaction with mobilization
timeFrame: Up to Day 5
measure: Inflammatory response
timeFrame: Up to Day 5
measure: Health care provider assessment
timeFrame: Up to Day 5
measure: Muscle wasting
timeFrame: Up to Day5
measure: Oxygen consumption during mobilization
timeFrame: Up to Day 5
measure: Oesophageal pressure
timeFrame: Up to Day 5
measure: Safety events
timeFrame: Up to Day 5
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: