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Completed

NCT Number: NCT04750265

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Critical Illness Polyneuromyopathy Disease Attributes Early Mobilization Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Rehabilitation Respiratory Tract Diseases Respiratory Tract Infections Robotics Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Univiversitätsmedizin Berlin

Mitte, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic assisted early mobilization

Device

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

Primary outcomes

  1. Level of mobilization

    Time frame: 5 days

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

  2. Level of mobilization

    Time frame: 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 outcomes

  1. Frequency of Mobilization

    Time frame: 5 days

    Frequency of early mobilization during mechanical ventilation

  2. Initiation of first Mobilization

    Time frame: 5 days

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

  3. Mobilization duration

    Time frame: 5 days

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

  4. Depth of sedation

    Time frame: 5 days

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

  5. Days of sedation

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

    Days under sedative medication during ICU stay

  6. Days of mechanical ventilation

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

    Days of mechanical ventilation during ICU stay

  7. Days of Intubation

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

    Days of Intubation during ICU stay

  8. Days of Delirium

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

    Days of Delirium during ICU stay

  9. MRC Score

    Time frame: One time point before ICU Discharge

    MRC Score at ICU Discharge

  10. Muscle wasting

    Time frame: 5 days

    Muscle wasting assessed using ultrasound measurement of the M. femoris

  11. Number of Health care provider

    Time frame: 5 days

    Number of Health care provider needed for mobilization

  12. Mortality

    Time frame: at 180 days after study start

    Mortality during ICU and Hospital stay and 180 days after admission at ICU

  13. Length of stay

    Time frame: Hospital stay (approx. 30 days)

    Length of stay at ICU , in Hospital (in days)

  14. Global function

    Time frame: at 180 days after study start

    Global function measured with WHODAS

  15. Health care provider assessment

    Time frame: 5 days

    Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)

  16. Safety events

    Time frame: 5 days after study start

    Frequency of safety events during mobilization

  17. Functional status

    Time frame: at 180 days after study start

    Measurement of ADLs/IADLs for which patients need assistance

  18. DRG workplace data

    Time frame: Hospital stay (approx. 30 days)

    expenses of the hospital stay

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Reactive Robotics GmbH

Registry information

Official study title

Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 11, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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