Clinical trial NCT05716451: Pilot Study on Device-assisted Mobilisation of Critically Ill Patients
Official title: Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Weakness
Critical Illness
Keywords: ICUAW
Muscle Weakness
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of mobilisation (IMS)
timeFrame: 28 Days
Secondary outcomes:
measure: Frequency of IMS ≥ 4
timeFrame: 28 Days
measure: Handgrip strength
timeFrame: 28 Days
measure: MRC Sum Score
timeFrame: 28 Days
measure: Diaphragma function
timeFrame: 28 Days
measure: CPAx Score
timeFrame: 28 Days
measure: Trunk Control Test
timeFrame: 28 Days
measure: Duration of MV
timeFrame: 180 Days
measure: Patient satisfaction with VRS
timeFrame: 28 Days
measure: Staff satisfaction with VRS
timeFrame: 28 Days
measure: Staff binding time
timeFrame: 28 Days
measure: ICU LOS
timeFrame: 180 Days
measure: Hospital LOS
timeFrame: 180 Days
measure: Time in rehabilitation and hospital
timeFrame: 180 Days
measure: (I)ADL
timeFrame: 180 Days
measure: Disability
timeFrame: 180 Days
measure: Quality of life
timeFrame: 180 Days
measure: Physical Function
timeFrame: 180 Days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Univiversitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
References: