Charité - Univiversitätsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
NCT Number: NCT05716451
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Berlin, State of Berlin, 10117, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive device-assisted mobilisation with LIANA
Time frame: 28 Days
Mean 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)
Time frame: 28 Days
Frequency of Days with IMS ≥ 4 till ICU discharge (or Day 28)
Time frame: 28 Days
Muscle strength measured using handgrip strength till ICU discharge (or Day 28)
Time frame: 28 Days
Muscle 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
Time frame: 28 Days
Diaphragm function by diaphragmatic thickening fraction using ultrasound till ICU discharge (or Day 28)
Time frame: 28 Days
The 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
Time frame: 28 Days
Trunk stability using the trunk control test during the ICU stay (or till Day 28)
Time frame: 180 Days
Duration of mechanical ventilation (MV) in days
Time frame: 28 Days
Patient satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 the worst score
Time frame: 28 Days
Staff satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 being worst score
Time frame: 28 Days
Staff binding time for mobilisation during the ICU stay (or Day 28)
Time frame: 180 Days
ICU length of stay in Days
Time frame: 180 Days
Hospital length of stays
Time frame: 180 Days
Time in rehabilitation facilities or hospital in days
Time frame: 180 Days
(Intrumental) Activities of Daily Living Score as measured by Iwashyna et al.; range 0-11, 0 the worst
Time frame: 180 Days
Disability measured with the WHODAS 2.0 score
Time frame: 180 Days
Quality 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/
Time frame: 180 Days
Physical function measured with the Barthel Score, scoring from 0-100 with 0 the worst
Charite University, Berlin, Germany
Other
Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support
Acronym: LIANA-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05591950
Critical Illness, Disease Attributes
Berlin, State of Berlin, Germany
View Trial DetailsNCT03347656
Atrophy, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT04284475
Critical Illness, Disease Attributes
Liège, Belgium
View Trial DetailsNCT04412330
COVID-19, Coronaviridae Infections
Lexington, Kentucky, United States
View Trial Details