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Early Mobilization in Ventilated sEpsis & Acute Respiratory Failure Study (EVER)

Primary Purpose

Early Mobility, Critically Ill

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
early mobilization
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Early Mobility focused on measuring early mobility, Sepsis, Acute respiratory failure, Intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

early mobilization Arm

non-early mobilization Arm

Arm Description

In addition to conventional bedside physical therapy, the mobilization program will be administered for 30 mins per session, two sessions per day, 7 days per week, until the patients are discharged from the ICU.

Conventional bedside physical therapy will be administered for 30 mins per session, one session per day, 5 days per week (only on working days), until the patients are discharged from the ICU.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of ICU stay
duration of hospitalization in ICU
Length of hospital stay
duration of hospitalization
Mechanical ventilation treatment
Duration of mechanical ventilation treatment (28-day ventilator-free days)
Delirium-free duration
Delirium-free duration (28-day delirium-free days)
FSS-ICU
Functional Status Score for Intensive Care Unit(FSS-ICU)
MRC sum score
Medical Research Council sum score (0-60;0-23,severe muscle weakness;24-35,moderate;36-47,mild)
Handgrip dynamometry
Handgrip dynamometry
TUG
Timed Up and Go Test (TUG)
30s CSS
30s chair sit and stand (30s CSS)
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
Health Care Costs
Comparison of Health Care Costs
Use of Health Care Services
Differences in the Use of Health Care Services
PICS surveys
Post Intensive Care Syndrome(PICS) surveys

Full Information

First Posted
July 22, 2020
Last Updated
October 5, 2020
Sponsor
Samsung Medical Center
Collaborators
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04582760
Brief Title
Early Mobilization in Ventilated sEpsis & Acute Respiratory Failure Study
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Korea Health Industry Development Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Mobility, Critically Ill
Keywords
early mobility, Sepsis, Acute respiratory failure, Intensive care unit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early mobilization Arm
Arm Type
Experimental
Arm Description
In addition to conventional bedside physical therapy, the mobilization program will be administered for 30 mins per session, two sessions per day, 7 days per week, until the patients are discharged from the ICU.
Arm Title
non-early mobilization Arm
Arm Type
No Intervention
Arm Description
Conventional bedside physical therapy will be administered for 30 mins per session, one session per day, 5 days per week (only on working days), until the patients are discharged from the ICU.
Intervention Type
Other
Intervention Name(s)
early mobilization
Other Intervention Name(s)
physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
FSS-ICU
Description
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
Secondary Outcome Measure Information:
Title
Length of ICU stay
Description
duration of hospitalization in ICU
Time Frame
Within 1 month of ICU discharge
Title
Length of hospital stay
Description
duration of hospitalization
Time Frame
Wihin 1 month of hospital discharge
Title
Mechanical ventilation treatment
Description
Duration of mechanical ventilation treatment (28-day ventilator-free days)
Time Frame
Within 24 hours of ICU discharge
Title
Delirium-free duration
Description
Delirium-free duration (28-day delirium-free days)
Time Frame
Within 24 hours of ICU discharge
Title
FSS-ICU
Description
Functional Status Score for Intensive Care Unit(FSS-ICU)
Time Frame
Wihin 24 hours of hospital discharge
Title
MRC sum score
Description
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
Title
Handgrip dynamometry
Description
Handgrip dynamometry
Time Frame
Wihin 24 hours of ICU discharge and hospital discharge
Title
TUG
Description
Timed Up and Go Test (TUG)
Time Frame
Wihin 24 hours of hospital discharge
Title
30s CSS
Description
30s chair sit and stand (30s CSS)
Time Frame
Wihin 24 hours of hospital discharge
Title
CPAx-respiratory function
Description
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
Title
Health Care Costs
Description
Comparison of Health Care Costs
Time Frame
1 year after discharged from the hospital
Title
Use of Health Care Services
Description
Differences in the Use of Health Care Services
Time Frame
1 year after discharged from the hospital
Title
PICS surveys
Description
Post Intensive Care Syndrome(PICS) surveys
Time Frame
1 month, 3 months, 6 months, 12 months of hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GeeYoung Suh, MD PhD
Phone
+82-2-3410-3429
Email
smccritcare@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Ryang Chung, MD PhD
Phone
+82-2-3410-3430
Email
chiryang.chung@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GeeYoung Suh, MD PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GeeYoung Suh, MD PhD
Phone
+82-2-3410-3429
Email
smccritcare@gmail.com
First Name & Middle Initial & Last Name & Degree
Chi Ryang Chung, MD PhD
Phone
+82-2-3410-3430
Email
chiryang.chung@gmail.com
First Name & Middle Initial & Last Name & Degree
GeeYoung Suh, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.improvelto.com/instruments/
Description
outcome instruments

Learn more about this trial

Early Mobilization in Ventilated sEpsis & Acute Respiratory Failure Study

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