Early Mobilization in Ventilated sEpsis & Acute Respiratory Failure Study

Critically Ill Clinical Trial

— EVER  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582760
• Other study ID #: 2019-11-143
• Secondary ID: HC19C0226
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: August 20, 2023

Study information

• Verified date: October 2020
• Source: Samsung Medical Center
• Contact: GeeYoung Suh, MD PhD
• Phone: +82-2-3410-3429
• Email: smccritcare[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 20, 2023
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Early Mobility
• Respiratory Insufficiency
• Sepsis

Intervention

Other:
• early mobilization
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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 24 hours of ICU discharge
Secondary	Length of ICU stay	duration of hospitalization in ICU	Within 1 month of ICU discharge
Secondary	Length of hospital stay	duration of hospitalization	Wihin 1 month of hospital discharge
Secondary	Mechanical ventilation treatment	Duration of mechanical ventilation treatment (28-day ventilator-free days)	Within 24 hours of ICU discharge
Secondary	Delirium-free duration	Delirium-free duration (28-day delirium-free days)	Within 24 hours of ICU discharge
Secondary	FSS-ICU	Functional Status Score for Intensive Care Unit(FSS-ICU)	Wihin 24 hours of hospital discharge
Secondary	MRC sum score	Medical Research Council sum score (0-60;0-23,severe muscle weakness;24-35,moderate;36-47,mild)	Wihin 24 hours of ICU discharge and hospital discharge
Secondary	Handgrip dynamometry	Handgrip dynamometry	Wihin 24 hours of ICU discharge and hospital discharge
Secondary	TUG	Timed Up and Go Test (TUG)	Wihin 24 hours of hospital discharge
Secondary	30s CSS	30s chair sit and stand (30s CSS)	Wihin 24 hours of hospital discharge
Secondary	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	Wihin 24 hours of ICU discharge and hospital discharge
Secondary	Health Care Costs	Comparison of Health Care Costs	1 year after discharged from the hospital
Secondary	Use of Health Care Services	Differences in the Use of Health Care Services	1 year after discharged from the hospital
Secondary	PICS surveys	Post Intensive Care Syndrome(PICS) surveys	1 month, 3 months, 6 months, 12 months of hospital discharge

External Links

•   outcome instruments