Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19

Charite University, Berlin, Germany20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19 Critical Illness Critical Illness Polyneuromyopathy Early Mobilization Rehabilitation Robotics

Interventions

Robotic assisted early mobilizationDEVICE

Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité - Univiversitätsmedizin Berlin

Mitte, State of Berlin, Germany

Outcomes

Primary Outcomes

Level of mobilization

Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)

Time frame: 5 days

Level of mobilization

Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)

Time frame: 5 days

Secondary Outcomes

Frequency of Mobilization

Frequency of early mobilization during mechanical ventilation

Time frame: 5 days

Initiation of first Mobilization

Time of first mobilization after admission on ICU (in hours)

Time frame: 5 days

Mobilization duration

Average duration of mobilization sessions during mechanical ventilation (in min)

Time frame: 5 days

Depth of sedation

Depth of sedation measured with RASS during the first 5 days after admission on ICU

Time frame: 5 days

Days of sedation

Days under sedative medication during ICU stay

Time frame: during ICU stay (normally up to 30 days)

Days of mechanical ventilation

Days of mechanical ventilation during ICU stay

Time frame: during ICU stay (normally up to 30 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.