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OpenTrials
Completed

NCT Number: NCT04423796

Robotic Assisted Early Mobilization in Ventilated ICU Patients

Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.

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Key information

Conditions

Critical Illness Polyneuromyopathy Critical Illness Disease Attributes Early Ambulation Pathologic Processes Pathological Conditions, Signs and Symptoms Rehabilitation

Age range

18 year and older

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
  • ICU stay > 72h at the time of enrolment

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

Treatment and study plan

Robotic-assisted early mobilization

Device

The early mobilization is done by robotic assistance devices.

Early mobilization

Other

Early mobilization by health care professionals without robotic assistance.

Primary outcomes

  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 outcomes

  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

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: an Interventional Randomized, Controlled Feasibility Study

Acronym: ROBEM-I

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Sep 8, 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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