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

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)

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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