Early mobilization in Ventilated sEpsis \& acute Respiratory failure Study: EVER Study
This is a multicenter, randomized, assessor-blinded study aiming to investigate the clinical effects of early mobilization in the ICU versus only conventional intensive care for improving physical function after ICU discharge, and after hospital discharge, in patients undergoing mechanical ventilation for acute respiratory failure or sepsis. Recently, several studies on rehabilitation treatment for patients in intensive care have reported that rehabilitation treatment is safe for patients with ventilators, elderly patients, and patients receiving continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO). In the United States and Europe, evidence of the stability and clinical outcomes of physical and occupational rehabilitation in the ICU have already been established. In contrast, there is a lack of cost analysis and health and sociological grounds for intensive care rehabilitation in Korea. Therefore, there is an urgent need to evaluate the clinical effects of early rehabilitation, starting on the very first day in the ICU, in patients with acute respiratory failure and sepsis, requiring mechanical ventilation. The clinical study plan of the current study is as follows. In ICU patients undergoing mechanical ventilation for acute respiratory failure or sepsis, the clinical effects of early mobilization on improving physical function will be assessed using FSS-ICU at discharge from the ICU and discharge from the hospital, and compared to those who did not receive early mobilization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
200
In patients who require mechanical ventilation for acute respiratory failure or sepsis (non-malignant tumor patients), early mobilization will be performed in addition to conventional bedside physical therapy, for 30 mins per session, two sessions per day, 7 days per week until the patients are discharged from the ICU.
Samsung Medical Center
Seoul, South Korea
FSS-ICU
Functional Status Score for the Intensive Care Unit Each task is evaluated using an eight-point ordinal scale ranging from 0 (unable to perform) to 7 (complete independence).The total score ranges from 0-35, with higher scores indicating better physical functioning.
Time frame: Within 24 hours of ICU discharge
Length of ICU stay
duration of hospitalization in ICU
Time frame: Within 1 month of ICU discharge
Length of hospital stay
duration of hospitalization
Time frame: Wihin 1 month of hospital discharge
Mechanical ventilation treatment
Duration of mechanical ventilation treatment (28-day ventilator-free days)
Time frame: Within 24 hours of ICU discharge
Delirium-free duration
Delirium-free duration (28-day delirium-free days)
Time frame: Within 24 hours of ICU discharge
FSS-ICU
Functional Status Score for Intensive Care Unit(FSS-ICU)
Time frame: Wihin 24 hours of hospital discharge
MRC sum score
Medical Research Council sum score (0-60;0-23,severe muscle weakness;24-35,moderate;36-47,mild)
Time frame: Wihin 24 hours of ICU discharge and hospital discharge
Handgrip dynamometry
Handgrip dynamometry
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Time frame: Wihin 24 hours of ICU discharge and hospital discharge
TUG
Timed Up and Go Test (TUG)
Time frame: Wihin 24 hours of hospital discharge
30s CSS
30s chair sit and stand (30s CSS)
Time frame: Wihin 24 hours of hospital discharge
CPAx-respiratory function
The Chelsea Critical Care Physical Assessment Tool Respiratory function: Level 0-5 Level 0, complete ventilator dependence. Mandatory breaths only. May be fully sedated/paralised; Level 1, Ventilator dependence. Mandatory breaths with some spontaneous effort; Level 2, Spontaneously breathing with continuous invasive or non-invasive ventilatory support; Level 3, Spontaneouslu breathing with intermittent invasive or non-invasive ventilatory support or continuous high flow oxygen (\>15L);Level 4, Receiving standard oxygen therapy (\<15L);Level 5, Self-ventilating with no oxygen therapy
Time frame: Wihin 24 hours of ICU discharge and hospital discharge
Health Care Costs
Comparison of Health Care Costs
Time frame: 1 year after discharged from the hospital
Use of Health Care Services
Differences in the Use of Health Care Services
Time frame: 1 year after discharged from the hospital
PICS surveys
Post Intensive Care Syndrome(PICS) surveys
Time frame: 1 month, 3 months, 6 months, 12 months of hospital discharge