Robotic Assisted Early Mobilization in Ventilated ICU Patients

Critical Illness Clinical Trial

— ROBEM-I  

Official title:

Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423796
• Other study ID #: ROBEM I
• Status: Completed
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: September 12, 2022

Study information

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

Clinical Trial Summary

Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 12, 2022
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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
• ICU stay > 72h at the time of enrolment Translated with www.DeepL.com/Translator (free version)

Related Conditions & MeSH terms

• Critical Illness
• Critical Illness Polyneuromyopathy
• Early Ambulation
• Rehabilitation

Intervention

Device:
• Robotic-assisted early mobilization
The early mobilization is done by robotic assistance devices.

Other:
• Early mobilization
Early mobilization by health care professionals without robotic assistance.

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	Feasibility of early mobilization	Frequency of early mobilization performed by one health care provider during mechanical ventilation	Up to Day 5
Secondary	Mobilization level	Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10	up to Day 5
Secondary	Mobilization duration	Duration of mobilzation sessions during mechanical ventilation	up to Day 5
Secondary	Frequency of mobilization	Frequency of early mobilization during mechanical ventilation	up to Day 5
Secondary	Pain level	Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12	up to Day 5
Secondary	Anxiety	Anxiety due to mobilization using a numerical scale (NRS 0-10)	up to Day 5
Secondary	Patient satisfaction with mobilization	Satisfaction with mobilization using a numerical scale (NRS 0-10)	Up to Day 5
Secondary	Inflammatory response	Zytokin change from before to after mobilization	Up to Day 5
Secondary	Health care provider assessment	Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)	Up to Day 5
Secondary	Muscle wasting	Muscle wasting will be assessed using ultrasound measurement of the M. femoris	Up to Day5
Secondary	Oxygen consumption during mobilization	Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization	Up to Day 5
Secondary	Oesophageal pressure	Oesophageal pressure will be measured during mobilization	Up to Day 5
Secondary	Safety events	Frequency of safety events during mobilization	Up to Day 5