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Pilot Study on Device-assisted Mobilisation of Critically Ill Patients

Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05716451
Acronym
LIANA-I
Enrollment
40
Registered
2023-02-08
Start date
2023-04-27
Completion date
2025-11-11
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Muscle Weakness

Keywords

ICUAW, Muscle Weakness

Brief summary

This Pilot study will hypothesize that patients with organ insufficiency and breathing assistance in our post-anaesthesia care unit (PACU) and ICU will be mobilized more often to an ICU mobility scale (IMS) ≥ 4 (i.e. standing) using the Liana® mobilizer. Therefore a randomized controlled pilot study will be conducted. The aim is to achieve an important physical function mile stone more often using this device. Secondary hypotheses are: 1. The intervention will relieve the burden of the health care staff in the unit 2. The intervention will positively influence the functional outcome of critically ill patients 3. The intervention is perceived as positive by the patients

Detailed description

Patients who have been treated in the ICU for a prolonged period of time often have a high degree of immobility. In this context, a state of generalized weakness associated with muscle atrophy (ICUAW) develops in approximately 40% of ICU patients. The severity of generalized weakness may be individual in each patient. It is certain that especially elderly patients and patients with prolonged immobilization have an increased incidence of ICUAW. Symptoms can be highly variable depending on the severity of the course. Some patients report weakness of the extremities to paresis and weakness of the respiratory muscles. Weakness of the respiratory musculature can lead to a prolonged weaning process of mechanical ventilation, prolonging the stay in the ICU. Functional impairments due to ICUAW may also persist many years after the ICU stay. If ICUAW is diagnosed promptly, outcome can be improved by targeted early mobilization. Early mobilization is defined as mobilization in the first 72 h from ICU admission. However, there are numerous barriers to the implementation of early mobilization in critically ill patients, so this remains a major challenge. Various studies have shown that patients can benefit from a high level of mobilization. For example, Scheffenbichler et al. showed that a high dose of mobilization was associated with increased independence of patients after discharge. The level of mobilization showed positive effects not only in this study, but also in Paton and colleagues. They were able to show that achieving a higher level of mobility (according to the Intensive Care Mobility Scale) was associated with improved outcome at six months. They found that achieving a higher level of mobilization positively affected the health status of patients, whereas increasing the number of mobilizations did not. With device-assisted mobilization, patients could be mobilized to standing position early and more frequently. The aim of this pilot study is to test whether mobilization of critically ill patients with ventilatory support using device-assisted mobilization leads to increased mobilization to standing (IMS 4) or beyond.

Interventions

DEVICEDevice-assisted mobilisation with the sit/stand stabilizer Liana

Non-invasive device-assisted mobilisation with LIANA

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Intensive care patient with ventilatory support and an expected intensive care stay of at least another 48 h * Age ≥ 18 years * Current length of intensive care stay \< 48 h

Exclusion criteria

* Moribund and critically ill * Suspected 6-month mortality \> 75%. * Increased intracranial pressure * Critically ill after cardiopulmonary resuscitation * Critically ill with primary neuromuscular disease or motor neuron disease * One or more amputated extremities * Patients, within 2h after surgery * Unstable fractures * Severe traumatic brain injury (e.g., brain and skull injuries) * Circulatory instability with norepinephrine \> 0.3 µg/kg/min * Patients for whom there is an indication for deep sedation (RASS -5) * Language barrier * Fitting of legs into leg trays is not possible due to e.g. patient weight

Design outcomes

Primary

MeasureTime frameDescription
Level of mobilisation (IMS)28 DaysMean level of mobilisation measured with the Intensive Car Unit Mobility Scale (IMS) till ICU discharge (or Day 28); IMS ranges from 0 (no mobilization) to 10 (independent walking)

Secondary

MeasureTime frameDescription
Handgrip strength28 DaysMuscle strength measured using handgrip strength till ICU discharge (or Day 28)
MRC Sum Score28 DaysMuscle strength measured using Medical Research Council (MRC) Sum Score till ICU discharge (or Day 28); MRC Sum Score ranges from 0 to 60, with 0 worst value
Diaphragma function28 DaysDiaphragm function by diaphragmatic thickening fraction using ultrasound till ICU discharge (or Day 28)
CPAx Score28 DaysThe Chelsea Critical Care Physical Assessment Tool (CPAx) during the ICU stay (or till Day 28); ranging from 0 to 50 with 0 the worst score
Trunk Control Test28 DaysTrunk stability using the trunk control test during the ICU stay (or till Day 28)
Duration of MV180 DaysDuration of mechanical ventilation (MV) in days
Patient satisfaction with VRS28 DaysPatient satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 the worst score
Staff satisfaction with VRS28 DaysStaff satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 being worst score
Frequency of IMS ≥ 428 DaysFrequency of Days with IMS ≥ 4 till ICU discharge (or Day 28)
ICU LOS180 DaysICU length of stay in Days
Hospital LOS180 DaysHospital length of stays
Time in rehabilitation and hospital180 DaysTime in rehabilitation facilities or hospital in days
(I)ADL180 Days(Intrumental) Activities of Daily Living Score as measured by Iwashyna et al.; range 0-11, 0 the worst
Disability180 DaysDisability measured with the WHODAS 2.0 score
Quality of life180 DaysQuality of life measured with the EQ-5D-5L. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Detail information is available at https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/
Physical Function180 DaysPhysical function measured with the Barthel Score, scoring from 0-100 with 0 the worst
Staff binding time28 DaysStaff binding time for mobilisation during the ICU stay (or Day 28)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026