Clinical trial NCT05071248: Evaluation of the Effect of Robot-assisted Early Mobilization - Project MobiStaR
Official title: Evaluation of the Effect of Robot-assisted Early Mobilization on Critically Ill Patients, on the Mobilisation Behaviour and Experience of Mobilizing Professionals and Organisational Processes in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Activation
Mobilization
Robotics
Keywords: robotics
intensive care unit
VEM
very early mobilization
feasibility
effects on patients' outcomes
mobilising professionals
Sonography
mixed methods
routine data
observations
interview
nursing sciences
physiotherapy
nurse
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Catholic University of Eichstätt-Ingolstadt
First posted: 2021-10-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The present study is a monocentric, prospective intervention study designed to evaluate the feasibility and

* to evaluate the feasibility and integration in the setting of the intensive care unit.
* the behavior and experience of the mobilizing specialists of the robot-assisted VEM is to be evaluated longitudinally (three data collection points).
* to compare robot-assisted VEM in critically ill ICU patients with non-robot-assisted early mobilization according to the standard of care of a historical patient population.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Within the MobiStaR project the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to increase the mobilization rate of critically ill intensive care patients significantly, possibly thereby increasing the rehabilitation outcomes for these patients and developing a new standard of care for robot-assisted early mobilization.

The intervention study will assess the organizational feasibility of robot-assisted early mobilization (starting in the first 72 hours after admission to the ICU), the behavior and experience of the mobilizing professionals and the effects on patient outcomes in terms of ventilation time, muscle mass (sonographic examination) and physical activity (measured by established scores such as Functional Status Score for ICU (FSS-ICU) and Medical Research Council (MRC) classification).

Detailed description: Early mobilization means the mobilization of critically ill patients in the early course after admission to the intensive care unit. The positive influence of early mobilization of critically ill patients on various aspects of patient outcomes has already been demonstrated. However, the implementation of early mobilization in clinical practice is difficult. Especially the high personnel effort is a barrier.

The Munich-based company Reactive Robotics (RR) is currently developing the world's first adaptive robotic assistance system VEMO©, which has CE approval for the planned indication and is to be used in the medium term for mobilizing intensive care patients.

Within the MobiStaR project, the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to significantly increase the mobilization rate of critically ill intensive care patients, possibly thereby increasing the rehabilitation results for these patients and developing a new standard of care for robot-assisted early mobilization. In this project, the robotic system will be used in anesthesiology intensive care units of the Ludwigs-Maximilians-University hospital.

Within this study, the effects of robot-assisted early mobilization will now be evaluated. This study comprises three study arms, in which (1) the feasibility and practicability of robot-assisted early mobilization, (2) the behavior and experience of the mobilizing professionals, and (3) the effect on patient outcomes will be evaluated.

The study is monocentric, prospective, interventional, does not include invasive procedures or blood sampling and has multiple data collection time points.

1. The feasibility of robot-assisted early mobilization surveys concomitantly how many VEM therapies can be implemented in how many patients as well as if and which adverse events occur.
2. The behavior and experience of the mobilizing professionals will be evaluated by using episodic interviews and standardized observations. Nurses with advanced training in anesthesia and intensive care, nurses and physiotherapists who have at least three years of professional experience in an intensive care unit as well as medical specialists with completed specialist training or a leading position in the intensive care unit will be included.
3. The effects on patient outcomes, primarily ventilation duration, muscle mass (sonographic examination) and physical activity (measured by established scores such as FSS-ICU and MRC classification), will be measured at different time points and compared with a historical patient population. Secondary factors such as delirium incidence, hemodynamic parameters, respiratory parameters but also longitudinal parameters such as ICU and hospital length of stay will be analyzed from routine data/patient records. Informed consenting patients undergoing a planned surgical procedure that is postoperatively associated with intensive care treatment and an anticipated duration of ventilation of more than 48 hours will be included. These patients will receive standardized early mobilization using the robotic system at either ten frequencies or for seven days. No invasive procedures such as blood sampling will be performed as part of the study. Outcomes will be compared with a historical comparison group to evaluate the effect of robot-assisted VEM (very early mobilization). Approximately 30 patients will be included. The outcomes will be compared with those of a historical group (n=30) treated with conventional early mobilization.

The intervention is planned for a duration of five to six months starting in September 2021.

Eligibility criteria: Inclusion Criteria:

* planned surgical intervention
* postoperative intensive medical and therapeutic treatment
* expected duration of ventilation \> 48 hours
* age ≥ 18 years
* preoperative informed consent by the patients in the study
* weight \>45 kg and \<135 kg
* body height \>1.50 m and \<1.95 m

Exclusion Criteria:

* patient refusal to participate in the study
* unable to give consent
* chronically bedridden before inclusion
* clinical Frailty Scale ≥ 7
* chronic ventilation (over 24h) before ICU admission
* increased intracranial pressure / risk for increased intracranial pressure / recent cerebral hemorrhage
* pregnancy
* pre-existing neuromuscular disease resulting in chronic limitation of strength and efficiency
* sternotomy / sternectomy during surgical procedure

Primary outcomes:
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination Area of the M.rec.femoris
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness M. quad. femoris
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination- motility diaphragm breathing
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm inspiration
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm exhalation
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity - FSS-ICU
timeFrame: 6 months
measure: Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity
timeFrame: 6 months
measure: Behavior and experience of the mobilizing professionals - qualitative interviews
timeFrame: 6 months
measure: Behavior and experience of the mobilizing professionals - qualitative observations
timeFrame: 6 months
measure: Feasibility in organizational processes - eligible patients
timeFrame: 6 months
measure: Feasibility in organizational processes - mobilizations
timeFrame: 6 months
measure: Feasibility in organizational processes - adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Delir
timeFrame: 6 months
measure: Consciousness
timeFrame: 6 months
measure: Sedation level
timeFrame: 6 months
measure: Pain (VAS)
timeFrame: 6 months
measure: health related quality of life
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: catecholamine demand
timeFrame: 6 months
measure: heart rate
timeFrame: 6 months
measure: cardiac output
timeFrame: 6 months
measure: oxygen consumption
timeFrame: 6 months
measure: respiration
timeFrame: 6 months
measure: ICU Score - SOFA
timeFrame: 6 months
measure: ICU Scores - APACHE II
timeFrame: 6 months
measure: ICU Scores - SAPS II
timeFrame: 6 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LudwigMaximilians
state: BY
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Michael Zoller, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Eichstätt-Ingolstadt
name: Inge Eberl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians - University of Munich
name: Eduard Kraft, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians - University of Munich
name: Uli Fischer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warmbein A, Schroeder I, Mehler-Klamt A, Rathgeber I, Huber J, Scharf C, Hubner L, Gutmann M, Biebl J, Lorenz A, Kraft E, Zoller M, Eberl I, Fischer U. Robot-assisted early mobilization of intensive care patients: a feasibility study protocol. Pilot Feasibility Stud. 2022 Nov 5;8(1):236. doi: 10.1186/s40814-022-01191-0.