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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Completed

Conditions

Rehabilitation
Robotics
Early Mobilization
Critical Illness Polyneuromyopathy
Critical Illness
Covid19

Treatments

Device: Robotic assisted early mobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT04750265
ROBEM II

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 100 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Robotic assisted early mobilization
Experimental group
Description:
Early mobilization therapy assisted with robotics
Treatment:
Device: Robotic assisted early mobilization
Standard Care
No Intervention group
Description:
Mobilization according to standard care by staff

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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