Pilot Study on Device-assisted Mobilisation of Critically Ill Patients (LIANA-I)

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

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

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Muscle Weakness
• Intervention / Treatment: Device: Device-assisted mobilisation with the sit/stand stabilizer Liana

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan J Schaller, MD; Phone Number: +49-30-450-5311052; Email: stefan.schaller@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Univiversitätsmedizin Berlin
    • Contact: Stefan J Schaller, MD; Phone Number: +49-30-450-5311052; Email: stefan.schaller@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Mobilization incl. support by the Liana. In the intervention group, Liana is used to train trunk stability in a sitting position. If this is successful, the patient is trained to stand. Mobilization to higher levels is performed according to clinical standards.	Device: Device-assisted mobilisation with the sit/stand stabilizer Liana; Non-invasive device-assisted mobilisation with LIANA
No Intervention: Control Group; Standard of Care without the use of the Liana. In the control group the therapy is carried out according to the ward standard without using the Liana.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of mobilisation (IMS)	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)	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of IMS ≥ 4	Frequency of Days with IMS ≥ 4 till ICU discharge (or Day 28)	28 Days
Handgrip strength	Muscle strength measured using handgrip strength till ICU discharge (or Day 28)	28 Days
Diaphragma function	Diaphragm function by diaphragmatic thickening fraction using ultrasound till ICU discharge (or Day 28)	28 Days
Trunk Control Test	Trunk stability using the trunk control test during the ICU stay (or till Day 28)	28 Days
Duration of MV	Duration of mechanical ventilation (MV) in days	180 Days
Staff binding time	Staff binding time for mobilisation during the ICU stay (or Day 28)	28 Days
ICU LOS	ICU length of stay in Days	180 Days
Hospital LOS	Hospital length of stays	180 Days
Time in rehabilitation and hospital	Time in rehabilitation facilities or hospital in days	180 Days
Disability	Disability measured with the WHODAS 2.0 score	180 Days
MRC Sum Score	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	28 Days
CPAx Score	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	28 Days
Patient satisfaction with VRS	Patient satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 the worst score	28 Days
Staff satisfaction with VRS	Staff satisfaction with mobilisation using a verbal rating scale (VRS 0-10), 0 being worst score	28 Days
(I)ADL	(Intrumental) Activities of Daily Living Score as measured by Iwashyna et al.; range 0-11, 0 the worst	180 Days
Quality of life	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/	180 Days
Physical Function	Physical function measured with the Barthel Score, scoring from 0-100 with 0 the worst	180 Days

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Stefan J Schaller, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Muscle Weakness; ICUAW
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Critical Illness; Paresis
• Other Study ID Numbers: LIANA-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan is to share deidentified data by reasonable scientific request and after signing an appropriate agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No