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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04750265
Recruitment Status : Completed
First Posted : February 11, 2021
Last Update Posted : September 10, 2022
Sponsor:
Collaborator:
Reactive Robotics GmbH
Information provided by (Responsible Party):
Stefan J Schaller, Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Covid19 Critical Illness Critical Illness Polyneuromyopathy Early Mobilization Rehabilitation Robotics Device: Robotic assisted early mobilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, parallel-group, open label pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)
Actual Study Start Date : March 29, 2021
Actual Primary Completion Date : July 24, 2021
Actual Study Completion Date : January 24, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robotic assisted early mobilization
Early mobilization therapy assisted with robotics
Device: Robotic assisted early mobilization
Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.

No Intervention: Standard Care
Mobilization according to standard care by staff



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750265


Locations
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Germany
Charité - Univiversitätsmedizin Berlin
Berlin-Mitte, Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Reactive Robotics GmbH
Investigators
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Principal Investigator: Stefan J Schaller, MD Charite University, Berlin, Germany
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Responsible Party: Stefan J Schaller, Deputy Clinical Director, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04750265    
Other Study ID Numbers: ROBEM II
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Depersonalized data can be requested from the PI after publication of the study for scientific purpose.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After publishing results.
Access Criteria: Data will be shared to other researchers on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan J Schaller, Charite University, Berlin, Germany:
COVID19
Early mobilization
robotics
Vemo
Additional relevant MeSH terms:
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COVID-19
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes