Robotic Assisted Early Mobilization in Ventilated ICU Patients

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

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

Conditions
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Critical Illness Polyneuromyopathy, Critical Illness, Early Ambulation, Rehabilitation

Intervention / Treatment
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* Device: Robotic-assisted early mobilization
* Other: Early mobilization


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, parallel-group, open label pilot trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic assisted early mobilization<br>Robotic assisted early mobilization started within 72 hours of ICU admission. | Device: Robotic-assisted early mobilization<br>* The early mobilization is done by robotic assistance devices.<br>|
| Active Comparator: Early mobilization<br>Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell. | Other: Early mobilization<br>* Early mobilization by health care professionals without robotic assistance.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early mobilization, pilot trial, feasibility trial, robotic assisted