Evaluation of the Effect of Robot-assisted Early Mobilization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-05-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Patient Activation Mobilization Robotics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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patients with robot-assisted early mobilization

All patients will receive a physical examination at various time points to assess physical functionality and muscle strength, as well as a sonographic examination of leg muscles, diaphragm, and lungs. These examinations should be performed on day -1 (preoperatively), on postoperative days 1,2,3, then once a week if the patient remains in the ICU, on day 28, on the day of discharge from the ICU, and on a follow-up examination approximately 3 months after discharge from the ICU.The follow-up examination should only take place if the patients present themselves at the hospital anyway due to medically indicated follow-up examinations (not study-related). Alternatively, patients can be asked about their condition by telephone.

Group Type ACTIVE_COMPARATOR

VEMO (Reactive Robotics GmbH)

Intervention Type DEVICE

The robot used for early mobilization is able to verticalize the patients in their bed without transfer and to generate a movement of the legs that measures and supports the patients' own movement. The device meets the requirements for mobilizing critically ill patients in an intensive care unit, maintaining hygiene standards and providing the best possible support for the patient's own movement.

patients with conventional early mobilization (historic group)

All patients fulfill the same criteria like the intervention group and receive conventional early mobilization.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VEMO (Reactive Robotics GmbH)

The robot used for early mobilization is able to verticalize the patients in their bed without transfer and to generate a movement of the legs that measures and supports the patients' own movement. The device meets the requirements for mobilizing critically ill patients in an intensive care unit, maintaining hygiene standards and providing the best possible support for the patient's own movement.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No