Clinical trial NCT04582760: Early Mobilization in Ventilated SEpsis & Acute Respiratory Failure Study
Official title: Clinical Effect of Early Mobilization in Patients with Acute Respiratory Failure or Sepsis Requiring Mechanical Ventilation (Multicenter Randomized Controlled Trial by the Korean ICU Early Mobilization Network)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Mobility
Critically Ill
Keywords: early mobility
Sepsis
Acute respiratory failure
Intensive care unit
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2020-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Early mobilization in Ventilated sEpsis \& acute Respiratory failure Study: EVER Study

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:You can participate in this clinical trial only if you meet all of the following criteria within 48 hours of ICU hospitalization.

* Those who voluntarily consent to participate in this clinical trial
* Those who are over the age of 18 years
* Patients who require mechanical ventilation for acute respiratory failure and sepsis (non-malignant tumor patients; excluding non-invasive mechanical ventilation and high-flow oxygen therapy)
* Patients with a Clinical Frailty Scale score of 1-4 points (physical condition prior to entering the ICU)
* Patients whose mechanical ventilation treatment is expected to last for more than 48 hours (evaluated at the time of study enrollment). However, if the patient has already begun mechanical ventilation treatment at another hospital, the time of airway intubation serves as the reference point. If it is difficult to confirm the exact time, the time of hospitalization is used as the reference point.

Exclusion Criteria:

* Patients with brain damage, psychiatric illness, or cognitive impairment making evaluation difficult
* Patients who are contraindicated for mobilization (active bleeding, deep vein thrombosis, increased brain pressure, open abdomen, iliac fracture, etc.
* Patients who do not meet the screening criteria for mobilization (however, if the ICU rehabilitation multidisciplinary team determines that mobilization can be started even if the patient does not meet the screening criteria below, the patient can be included in the study) A. Patients with a Richmond Agitation Sedation Scale (RASS) score less than -2 or greater than +2 B. Patients who have at least one of PEEP ≥ 10cmH2O, FiO2 ≥ 0.6, SpO2 \< 90%, respiratory rate ≥ 35/min C. Patients who have at least one of systolic blood pressure \<90 mmHg or\> 200 mmHg, average arterial pressure\> 110 mmHg or \<65 mmHg, pulse rate\> 130/min or \<60/min or newly developed arrhythmia, or currently increasing the dose of inotropic agents.
* Patients who are pregnant
* Prisoners
* Patients with limitations in treatments (e.g., a declaration relating to life-sustaining treatment; or, if the patient is expected to die during hospitalization, if life-sustaining treatment is expected to be discontinued, or if the investigator expects a high probability of mortality (\>50%))
* Patients who have already undergone mechanical ventilation treatment for more than 72 hours (if the patient is re-intubated within 36 hours after airway intubation, the treatment time is calculated as the continued mechanical ventilation time. If the total mechanical ventilation time is within 72 hours, the patient can be registered for the study)
* Patients who take neuromuscular blockers
* Patients whose physical function is impaired due to brain or spinal cord diseases
* Patients who weigh over 100kg
* Patients who maintain airway intubation and mechanical ventilation only to maintain airway hygiene
* Post-cardiac pulmonary resuscitation patients
* Those who are unsuitable for participation in the clinical trial due to other reasons including the results of clinical laboratory tests, according to the judgment of one of the investigators.

Primary outcomes:
measure: FSS-ICU
timeFrame: Within 24 hours of ICU discharge
Secondary outcomes:
measure: Length of ICU stay
timeFrame: Within 1 month of ICU discharge
measure: Length of hospital stay
timeFrame: Wihin 1 month of hospital discharge
measure: Mechanical ventilation treatment
timeFrame: Within 24 hours of ICU discharge
measure: Delirium-free duration
timeFrame: Within 24 hours of ICU discharge
measure: FSS-ICU
timeFrame: Wihin 24 hours of hospital discharge
measure: MRC sum score
timeFrame: Wihin 24 hours of ICU discharge and hospital discharge
measure: Handgrip dynamometry
timeFrame: Wihin 24 hours of ICU discharge and hospital discharge
measure: TUG
timeFrame: Wihin 24 hours of hospital discharge
measure: 30s CSS
timeFrame: Wihin 24 hours of hospital discharge
measure: CPAx-respiratory function
timeFrame: Wihin 24 hours of ICU discharge and hospital discharge
measure: Health Care Costs
timeFrame: 1 year after discharged from the hospital
measure: Use of Health Care Services
timeFrame: 1 year after discharged from the hospital
measure: PICS surveys
timeFrame: 1 month, 3 months, 6 months, 12 months of hospital discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: GeeYoung Suh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: