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

NCT ID: NCT04750265

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-02-03

Brief Summary

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

Conditions

Covid19; Critical Illness; Critical Illness Polyneuromyopathy; Early Mobilization; Rehabilitation; Robotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic assisted early mobilization

Early mobilization therapy assisted with robotics

Group Type: EXPERIMENTAL

Robotic assisted early mobilization

Intervention Type: DEVICE

Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.

Standard Care

Mobilization according to standard care by staff

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Robotic assisted early mobilization

Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reactive Robotics GmbH

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan J Schaller

Deputy Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Univiversitätsmedizin Berlin

Mitte, State of Berlin, Germany

Countries

Germany

Other Identifiers

ROBEM II

Identifier Type: -

Identifier Source: org_study_id