Evaluation of the Effect of Robot-assisted Early Mobilization - Project MobiStaR

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Robotics; Patient Activation; Mobilization

Treatments: Device: VEMO (Reactive Robotics GmbH)

Study type: Interventional

Funder types: Other

Identifiers

NCT05071248

16SV842

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

patients with robot-assisted early mobilization

Active Comparator group

Description:

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.

Treatment:

Device: VEMO (Reactive Robotics GmbH)

patients with conventional early mobilization (historic group)

No Intervention group

Description:

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