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Robotic Assisted Early Mobilization in Ventilated ICU Patients (ROBEM-I)

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: NCT04423796
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
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 robotic assisted early mobilization vs. early mobilization in critically ill patients.

Condition or disease Intervention/treatment Phase
Critical Illness Polyneuromyopathy Critical Illness Early Ambulation Rehabilitation Device: Robotic-assisted early mobilization Other: Early mobilization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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: an Interventional Randomized, Controlled Feasibility Study
Actual Study Start Date : November 13, 2020
Actual Primary Completion Date : August 14, 2022
Estimated Study Completion Date : September 12, 2022

Arm Intervention/treatment
Experimental: Robotic assisted early mobilization
Robotic assisted early mobilization started within 72 hours of ICU admission.
Device: Robotic-assisted early mobilization
The early mobilization is done by robotic assistance devices.

Active Comparator: Early mobilization
Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.
Other: Early mobilization
Early mobilization by health care professionals without robotic assistance.




Primary Outcome Measures :
  1. Feasibility of early mobilization [ Time Frame: Up to Day 5 ]
    Frequency of early mobilization performed by one health care provider during mechanical ventilation


Secondary Outcome Measures :
  1. Mobilization level [ Time Frame: up to Day 5 ]
    Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10

  2. Mobilization duration [ Time Frame: up to Day 5 ]
    Duration of mobilzation sessions during mechanical ventilation

  3. Frequency of mobilization [ Time Frame: up to Day 5 ]
    Frequency of early mobilization during mechanical ventilation

  4. Pain level [ Time Frame: up to Day 5 ]
    Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12

  5. Anxiety [ Time Frame: up to Day 5 ]
    Anxiety due to mobilization using a numerical scale (NRS 0-10)

  6. Patient satisfaction with mobilization [ Time Frame: Up to Day 5 ]
    Satisfaction with mobilization using a numerical scale (NRS 0-10)

  7. Inflammatory response [ Time Frame: Up to Day 5 ]
    Zytokin change from before to after mobilization

  8. Health care provider assessment [ Time Frame: Up to Day 5 ]
    Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)

  9. Muscle wasting [ Time Frame: Up to Day5 ]
    Muscle wasting will be assessed using ultrasound measurement of the M. femoris

  10. Oxygen consumption during mobilization [ Time Frame: Up to Day 5 ]
    Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization

  11. Oesophageal pressure [ Time Frame: Up to Day 5 ]
    Oesophageal pressure will be measured during mobilization

  12. Safety events [ Time Frame: Up to Day 5 ]
    Frequency of safety events during mobilization



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Ages Eligible for Study:   18 Years and older   (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
  • ICU stay > 72h at the time of enrolment

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


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): NCT04423796


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: NCT04423796    
Other Study ID Numbers: ROBEM I
First Posted: June 9, 2020    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: Anonymized data can be requested from the PI after publication of the study for scientific purpose.
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:
Early mobilization
pilot trial
feasibility trial
robotic assisted
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes