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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750265
• Other study ID #: ROBEM II
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: February 3, 2022

Study information

• Verified date: August 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 3, 2022
• Est. primary completion date: August 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Critical Illness
• Critical Illness Polyneuromyopathy
• Early Mobilization
• Rehabilitation
• Robotics

Intervention

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

Locations

Country	Name	City	State
Germany	Charité - Univiversitätsmedizin Berlin	Berlin-Mitte	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Reactive Robotics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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