Critical Illness, Critical Illness Polyneuromyopathy, Early Ambulation, Rehabilitation
Conditions
Keywords
Early mobilization, pilot trial, feasibility trial, robotic assisted
Brief summary
Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.
Interventions
DEVICERobotic-assisted early mobilization
The early mobilization is done by robotic assistance devices.
OTHEREarly mobilization
Early mobilization by health care professionals without robotic assistance.
Sponsors
Reactive Robotics GmbH
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled, parallel-group, open label pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of early mobilization | Up to Day 5 | Frequency of early mobilization performed by one health care provider during mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobilization level | up to Day 5 | Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 0-10 |
| Mobilization duration | up to Day 5 | Duration of mobilzation sessions during mechanical ventilation |
| Frequency of mobilization | up to Day 5 | Frequency of early mobilization during mechanical ventilation |
| Pain level | up to Day 5 | Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12 |
| Anxiety | up to Day 5 | Anxiety due to mobilization using a numerical scale (NRS 0-10) |
| Patient satisfaction with mobilization | Up to Day 5 | Satisfaction with mobilization using a numerical scale (NRS 0-10) |
| Health care provider assessment | Up to Day 5 | Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5) |
| Muscle wasting | Up to Day5 | Muscle wasting will be assessed using ultrasound measurement of the M. femoris |
| Oxygen consumption during mobilization | Up to Day 5 | Oxygen consupmtion during mobilization will be measured using calorimetrie during mobilization |
| Oesophageal pressure | Up to Day 5 | Oesophageal pressure will be measured during mobilization |
| Safety events | Up to Day 5 | Frequency of safety events during mobilization |
| Inflammatory response | Up to Day 5 | Zytokin change from before to after mobilization |
Countries
Germany
Outcome results
None listed