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

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Charité University Medicine Berlin

Status

Completed

Conditions

Rehabilitation
Critical Illness
Critical Illness Polyneuromyopathy
Early Ambulation

Treatments

Device: Robotic-assisted early mobilization
Other: Early mobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT04423796
ROBEM I

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

Robotic assisted early mobilization
Experimental group
Description:
Robotic assisted early mobilization started within 72 hours of ICU admission.
Treatment:
Device: Robotic-assisted early mobilization
Early mobilization
Active Comparator group
Description:
Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.
Treatment:
Other: Early mobilization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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