Robotic Assisted Early Mobilization in Ventilated ICU Patients

Not Applicable

Completed

• Conditions: Early Ambulation; Rehabilitation; Critical Illness Polyneuromyopathy; Critical Illness
• Interventions: Other: Early mobilization; Device: Robotic-assisted early mobilization

• Registration Number: NCT04423796
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-06
• Study First Posted: 2020-06-09
• Study Start: 2020-11-13
• Primary Completion: 2022-08-14
• Study Completion: 2022-09-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early mobilization	Early mobilization	Early mobilization started within 72 hours of ICU admission without the use of a robotic assistance. Mobilization is done by personell.
Robotic assisted early mobilization	Robotic-assisted early mobilization	Robotic assisted early mobilization started within 72 hours of ICU admission.

Primary Outcome Measures

Name	Time	Method
Feasibility of early mobilization	Up to Day 5	Frequency of early mobilization performed by one health care provider during mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Mobilization level	up to Day 5	Mobilization level during mechanical ventilation using the ICU Mobility Scale (IMS) ranging from 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)
Anxiety	up to Day 5	Anxiety due to mobilization using a numerical scale (NRS 0-10)
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
Safety events	Up to Day 5	Frequency of safety events during mobilization
Pain level	up to Day 5	Pain level at mobilization using a numerical scale (NRS 0-10) or BPS 3-12
Patient satisfaction with mobilization	Up to Day 5	Satisfaction with mobilization using a numerical scale (NRS 0-10)
Frequency of mobilization	up to Day 5	Frequency of early mobilization during mechanical ventilation
Oesophageal pressure	Up to Day 5	Oesophageal pressure will be measured during mobilization
Mobilization duration	up to Day 5	Duration of mobilzation sessions during mechanical ventilation
Inflammatory response	Up to Day 5	Zytokin change from before to after mobilization

Trial Locations

Locations (1)

Charité - Univiversitätsmedizin Berlin; 🇩🇪 Berlin-Mitte, Berlin, Germany