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

Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)

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

Study Overview

• Status: Completed
• Conditions: Critical Illness; Covid19; Rehabilitation; Robotics; Early Mobilization; Critical Illness Polyneuromyopathy
• Intervention / Treatment: Device: Robotic assisted early mobilization

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin
    • Berlin-Mitte, Berlin, Germany, 10117
      • Charité - Univiversitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic assisted early mobilization; Early mobilization therapy assisted with robotics	Device: Robotic assisted early mobilization; Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
No Intervention: Standard Care; Mobilization according to standard care by staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Mobilization	Frequency of early mobilization during mechanical ventilation	5 days
Initiation of first Mobilization	Time of first mobilization after admission on ICU (in hours)	5 days
Mobilization duration	Average duration of mobilization sessions during mechanical ventilation (in min)	5 days
Depth of sedation	Depth of sedation measured with RASS during the first 5 days after admission on ICU	5 days
Days of sedation	Days under sedative medication during ICU stay	during ICU stay (normally up to 30 days)
Days of mechanical ventilation	Days of mechanical ventilation during ICU stay	during ICU stay (normally up to 30 days)
Days of Intubation	Days of Intubation during ICU stay	during ICU stay (normally up to 30 days)
Days of Delirium	Days of Delirium during ICU stay	during ICU stay (normally up to 30 days)
MRC Score	MRC Score at ICU Discharge	One time point before ICU Discharge
Muscle wasting	Muscle wasting assessed using ultrasound measurement of the M. femoris	5 days
Number of Health care provider	Number of Health care provider needed for mobilization	5 days
Mortality	Mortality during ICU and Hospital stay and 180 days after admission at ICU	at 180 days after study start
Length of stay	Length of stay at ICU , in Hospital (in days)	Hospital stay (approx. 30 days)
Global function	Global function measured with WHODAS	at 180 days after study start
Health care provider assessment	Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)	5 days
Safety events	Frequency of safety events during mobilization	5 days after study start
Functional status	Measurement of ADLs/IADLs for which patients need assistance	at 180 days after study start
DRG workplace data	expenses of the hospital stay	Hospital stay (approx. 30 days)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Reactive Robotics GmbH
• Investigators: Principal Investigator: Stefan J Schaller, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): August 8, 2021
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: COVID19; Early mobilization; robotics; Vemo
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Critical Illness
• Other Study ID Numbers: ROBEM II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Depersonalized data can be requested from the PI after publication of the study for scientific purpose.
• IPD Sharing Time Frame: After publishing results.
• IPD Sharing Access Criteria: Data will be shared to other researchers on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No