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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05071248
Other study ID # 16SV842
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2021
Est. completion date May 15, 2022

Study information

Verified date October 2023
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 15, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Germany LudwigMaximilians Munich BY

Sponsors (3)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich Catholic University of Eichstätt-Ingolstadt, German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration changes in ventilation duration (in hours) in comparison to a historical patient group 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination Area of the M.rec.femoris muscle mass (sonographic examination, in millimeters): Area of the M. rec. femoris in comparison to a historical patient group (in cm²) 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness M. quad. femoris muscle mass: Thickness M. quad. Femoris (in cm²) in comparison to a historical patient group 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination- motility diaphragm breathing muscle mass: motility of the diaphragm during breathing (in cm) in comparison to a historical patient group 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm inspiration muscle mass: Thickness of diaphragm during inspiration (in cm) in comparison to a historical patient group 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm exhalation muscle mass: Thickness of diaphragm during exhalation (in cm) in comparison to a historical patient group 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity - FSS-ICU physical activity measured using the score FSS-ICU (0 -35) in comparison to a historical patient group. A higher value means a better outcome. 6 months
Primary Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity physical activity on upper and lower extremity measured using the Medical Research Council (MRC) score in comparison to a historical patient group. (0=absent muscle contraction, 1=visible muscle contraction, 2=movement when gravity is eliminated, 3=active movement against gravity, 4=active movement against resistance, 5=normal strength.) 6 months
Primary Behavior and experience of the mobilizing professionals - qualitative interviews subjectively experienced emotions, motivating and challenging factors - evaluated with a semi-structured interview guideline 6 months
Primary Behavior and experience of the mobilizing professionals - qualitative observations behavior and body posture during the mobilization - evaluated with a standardized observation sheet 6 months
Primary Feasibility in organizational processes - eligible patients Frequency of eligible patients (count per week: included patients in the study/ new eligible patients in the ICUs) 6 months
Primary Feasibility in organizational processes - mobilizations frequency of robot-assisted mobilizations (per patient per day) 6 months
Primary Feasibility in organizational processes - adverse events adverse events (count of patient-related, user-related or technology-related adverse events) 6 months
Secondary Delir Delir incidence using the CAM ICU: number of days without Delir. 1 = pathological; 2 = normal; 3 = not performed in comparison to a historical patient group 6 months
Secondary Consciousness level of consciousness using the Glasgow Coma Scale (3-15) in comparison to a historical patient group 6 months
Secondary Sedation level Sedation level using the Richmond Agitation Sedation Scale (RASS) (-5 - +5) in comparison to a historical patient group 6 months
Secondary Pain (VAS) Pain - with the use of the Visual Analog Scale (VAS) (before and after mobilization) (0-10) in comparison to a historical patient group 6 months
Secondary health related quality of life Health-related quality of life after 3 months using the the SF-36 (Short form questionnaire) (0-100) in comparison to a historical patient group 6 months
Secondary Blood pressure hemodynamics - Blood pressure (in mmHg) in comparison to a historical patient group 6 months
Secondary catecholamine demand hemodynamics - catecholamine demand (cumulative over 24 hours) in comparison to a historical patient group 6 months
Secondary heart rate hemodynamics - heart rate (1/min) in comparison to a historical patient group 6 months
Secondary cardiac output hemodynamics - Cardiac output (in l/min) in comparison to a historical patient group 6 months
Secondary oxygen consumption hemodynamics - Oxygen consumption (in l) in comparison to a historical patient group 6 months
Secondary respiration respiration- Maximum respiratory rate for 24h in comparison to a historical patient group 6 months
Secondary ICU Score - SOFA ICU Scores like Sepsis-related organ failure assessment score (SOFA) (0-24) in comparison to a historical patient group. A higher value means a worse outcome. 6 months
Secondary ICU Scores - APACHE II ICU Scores like Acute Physiology and Chronic Health Disease Classification System II (APACHE II) (0-71) in comparison to a historical patient group. A higher value means a worse outcome. 6 months
Secondary ICU Scores - SAPS II ICU Scores like Simplified Acute Physiology Score II (SAPS II) (0-163) in comparison to a historical patient group. A higher value means a worse outcome. 6 months
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