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

• ClinicalTrials.gov Identifier: NCT04423796
• Recruitment Status: Active, not recruiting
• First Posted: June 9, 2020
• Last Update Posted: September 10, 2022
• Sponsor: Charite University, Berlin, Germany
• Collaborator: Reactive Robotics GmbH
• Information provided by (Responsible Party): Stefan J Schaller, Charite University, Berlin, Germany

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Critical Illness Polyneuromyopathy; Critical Illness; Early Ambulation; Rehabilitation	Device: Robotic-assisted early mobilization; Other: Early mobilization	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, controlled, parallel-group, open label pilot trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study
• Actual Study Start Date: November 13, 2020
• Actual Primary Completion Date: August 14, 2022
• Estimated Study Completion Date: September 12, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of early mobilization [ Time Frame: Up to Day 5 ]
   Frequency of early mobilization performed by one health care provider during mechanical ventilation

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Germany

Charité - Univiversitätsmedizin Berlin

Berlin-Mitte, Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Reactive Robotics GmbH

Investigators

• Principal Investigator: Stefan J Schaller, MD; Charite University, Berlin, Germany

More Information

• Responsible Party: Stefan J Schaller, Deputy Clinical Director, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04423796
• Other Study ID Numbers: ROBEM I
• First Posted: June 9, 2020
• Last Update Posted: September 10, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Anonymized data can be requested from the PI after publication of the study for scientific purpose.
• Time Frame: After publishing results.
• Access Criteria: Data will be shared to other researchers on reasonable request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefan J Schaller, Charite University, Berlin, Germany:

Early mobilization; pilot trial; feasibility trial; robotic assisted

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes