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

NCT04750265 | Completed

• 1 other identifier: ROBEM II
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

COVID19; Early mobilization; robotics; Vemo

Outcome Measures

Primary Outcomes (2)

• Level of mobilization

  Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)

  5 days

• Level of mobilization

  Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)

  5 days

Secondary Outcomes (18)

• Frequency of Mobilization

  5 days

• Initiation of first Mobilization

  5 days

• Mobilization duration

  5 days

• Depth of sedation

  5 days

• Days of sedation

  during ICU stay (normally up to 30 days)

Study Arms (2)

Robotic assisted early mobilization

EXPERIMENTAL

Early mobilization therapy assisted with robotics

Device: Robotic assisted early mobilization

Standard Care

NO INTERVENTION

Mobilization according to standard care by staff

Interventions

Robotic assisted early mobilization DEVICE

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

Robotic assisted early mobilization

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Invasive mechanically ventilated and expected to be ventilated for another 24 hours
• Cardiovascular stability, allowing mobilization
• Respiratory stability, allowing mobilization

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Reactive Robotics GmbH: collaborator

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Mitte, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

COVID-19; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan J Schaller, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Director

Model Details: Randomized, controlled, parallel-group, open label pilot trial

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 11, 2021
• Study Start: March 29, 2021
• Primary Completion: August 8, 2021
• Study Completion: February 3, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publishing results.
• Access Criteria: Data will be shared to other researchers on reasonable request.

Locations

DE (1)