Robotic Assisted Early Mobilization in Ventilated ICU Patients (ROBEM-I)

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

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

Study Overview

• Status: Completed
• Conditions: Critical Illness; Rehabilitation; Early Ambulation; Critical Illness Polyneuromyopathy
• Intervention / Treatment: Device: Robotic-assisted early mobilization; Other: Early mobilization

• Study Type: Interventional
• Enrollment (Actual): 21
• 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 and older (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
• ICU stay > 72h at the time of enrolment

Translated with www.DeepL.com/Translator (free version)

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; Robotic assisted early mobilization started within 72 hours of ICU admission.	Device: Robotic-assisted early mobilization; The early mobilization is done by robotic assistance devices.
Active Comparator: Early mobilization; Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.	Other: Early mobilization; Early mobilization by health care professionals without robotic assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of early mobilization	Frequency of early mobilization performed by one health care provider during mechanical ventilation	Up to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobilization level	Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10	up to Day 5
Mobilization duration	Duration of mobilzation sessions during mechanical ventilation	up to Day 5
Frequency of mobilization	Frequency of early mobilization during mechanical ventilation	up to Day 5
Pain level	Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12	up to Day 5
Anxiety	Anxiety due to mobilization using a numerical scale (NRS 0-10)	up to Day 5
Patient satisfaction with mobilization	Satisfaction with mobilization using a numerical scale (NRS 0-10)	Up to Day 5
Inflammatory response	Zytokin change from before to after mobilization	Up to Day 5
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
Muscle wasting	Muscle wasting will be assessed using ultrasound measurement of the M. femoris	Up to Day5
Oxygen consumption during mobilization	Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization	Up to Day 5
Oesophageal pressure	Oesophageal pressure will be measured during mobilization	Up to Day 5
Safety events	Frequency of safety events during mobilization	Up to Day 5

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): November 13, 2020
• Primary Completion (Actual): August 14, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 6, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Early mobilization; pilot trial; feasibility trial; robotic assisted
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: ROBEM I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized 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.

Drug and device information, study documents

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