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

Primary Purpose

Critical Illness Polyneuromyopathy, Critical Illness, Early Ambulation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Robotic-assisted early mobilization
Early mobilization
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness Polyneuromyopathy focused on measuring Early mobilization, pilot trial, feasibility trial, robotic assisted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Charité - Univiversitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic assisted early mobilization

Early mobilization

Arm Description

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

Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.

Outcomes

Primary Outcome Measures

Feasibility of early mobilization
Frequency of early mobilization performed by one health care provider during mechanical ventilation

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2020
Last Updated
September 7, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Reactive Robotics GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04423796
Brief Title
Robotic Assisted Early Mobilization in Ventilated ICU Patients
Acronym
ROBEM-I
Official Title
Robotic Assisted Early Mobilization in Ventilated ICU Patients: an Interventional Randomized, Controlled Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
August 14, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Reactive Robotics GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness Polyneuromyopathy, Critical Illness, Early Ambulation, Rehabilitation
Keywords
Early mobilization, pilot trial, feasibility trial, robotic assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, parallel-group, open label pilot trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic assisted early mobilization
Arm Type
Experimental
Arm Description
Robotic assisted early mobilization started within 72 hours of ICU admission.
Arm Title
Early mobilization
Arm Type
Active Comparator
Arm Description
Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.
Intervention Type
Device
Intervention Name(s)
Robotic-assisted early mobilization
Intervention Description
The early mobilization is done by robotic assistance devices.
Intervention Type
Other
Intervention Name(s)
Early mobilization
Intervention Description
Early mobilization by health care professionals without robotic assistance.
Primary Outcome Measure Information:
Title
Feasibility of early mobilization
Description
Frequency of early mobilization performed by one health care provider during mechanical ventilation
Time Frame
Up to Day 5
Secondary Outcome Measure Information:
Title
Mobilization level
Description
Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10
Time Frame
up to Day 5
Title
Mobilization duration
Description
Duration of mobilzation sessions during mechanical ventilation
Time Frame
up to Day 5
Title
Frequency of mobilization
Description
Frequency of early mobilization during mechanical ventilation
Time Frame
up to Day 5
Title
Pain level
Description
Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12
Time Frame
up to Day 5
Title
Anxiety
Description
Anxiety due to mobilization using a numerical scale (NRS 0-10)
Time Frame
up to Day 5
Title
Patient satisfaction with mobilization
Description
Satisfaction with mobilization using a numerical scale (NRS 0-10)
Time Frame
Up to Day 5
Title
Inflammatory response
Description
Zytokin change from before to after mobilization
Time Frame
Up to Day 5
Title
Health care provider assessment
Description
Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)
Time Frame
Up to Day 5
Title
Muscle wasting
Description
Muscle wasting will be assessed using ultrasound measurement of the M. femoris
Time Frame
Up to Day5
Title
Oxygen consumption during mobilization
Description
Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization
Time Frame
Up to Day 5
Title
Oesophageal pressure
Description
Oesophageal pressure will be measured during mobilization
Time Frame
Up to Day 5
Title
Safety events
Description
Frequency of safety events during mobilization
Time Frame
Up to Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan J Schaller, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Univiversitätsmedizin Berlin
City
Berlin-Mitte
State/Province
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Robotic Assisted Early Mobilization in Ventilated ICU Patients

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