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Early MobilityEVERNCT04582760

Early Mobilization in Ventilated SEpsis & Acute Respiratory Failure Study

A study testing early mobilization in people with Early Mobility and Critically Ill, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Early mobilization in Ventilated sEpsis \& acute Respiratory failure Study: EVER Study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early Mobility, Critically Ill
What is being tested?
early mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSouth Korea
Study dates
11 Sep 2020to 31 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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%))
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this 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)

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

Read the 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.

Being tested
early mobilization
Keywords
early mobility, Sepsis, Acute respiratory failure, Intensive care unit
Medical subject headings
Critical Illness, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early mobilizationOther

    Also called physical therapy

    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.

Study groups in NCT04582760
Study groupRoleWhat they receive
early mobilization ArmExperimentalIn 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.
Receives: Other: early mobilization
non-early mobilization ArmNo interventionConventional 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 24 hours of ICU discharge

Secondary outcomes (13)

  1. Length of ICU stay

    duration of hospitalization in ICU

    Measured: Within 1 month of ICU discharge

  2. Length of hospital stay

    duration of hospitalization

    Measured: Wihin 1 month of hospital discharge

  3. Mechanical ventilation treatment

    Duration of mechanical ventilation treatment (28-day ventilator-free days)

    Measured: Within 24 hours of ICU discharge

  4. Delirium-free duration

    Delirium-free duration (28-day delirium-free days)

    Measured: Within 24 hours of ICU discharge

  5. FSS-ICU

    Functional Status Score for Intensive Care Unit(FSS-ICU)

    Measured: Wihin 24 hours of hospital discharge

  6. MRC sum score

    Medical Research Council sum score (0-60;0-23,severe muscle weakness;24-35,moderate;36-47,mild)

    Measured: Wihin 24 hours of ICU discharge and hospital discharge

  7. Handgrip dynamometry

    Handgrip dynamometry

    Measured: Wihin 24 hours of ICU discharge and hospital discharge

  8. TUG

    Timed Up and Go Test (TUG)

    Measured: Wihin 24 hours of hospital discharge

  9. 30s CSS

    30s chair sit and stand (30s CSS)

    Measured: Wihin 24 hours of hospital discharge

  10. 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

    Measured: Wihin 24 hours of ICU discharge and hospital discharge

  11. Health Care Costs

    Comparison of Health Care Costs

    Measured: 1 year after discharged from the hospital

  12. Use of Health Care Services

    Differences in the Use of Health Care Services

    Measured: 1 year after discharged from the hospital

  13. PICS surveys

    Post Intensive Care Syndrome(PICS) surveys

    Measured: 1 month, 3 months, 6 months, 12 months of hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start11 Sep 2020
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582760
Sponsor's protocol ID
2019-11-143
Other IDs
HC19C0226
Acronym
EVER
Status last verified
Jan 2025
First submitted
22 Jul 2020
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chung CR, Hong SK, Kang D, Ko RE, Cho J, Kim W, Do JG, Shin MJ, Shin YB, Ahn SY, Won YH, Lee SI, Lee HJ, Lee HB, Jang M, Kang J, Suh GY. Early mobilization for mechanical ventilation for sepsis or acute respiratory failure (EVER): a multicenter randomized controlled trial with 12-month outcomes. Intensive Care Med. 2026 Aug 26. doi: 10.1007/s00134-026-08598-w. Online ahead of print.

    PubMed 42645557

Questions about this trial

What is this clinical trial studying?

A study testing early mobilization in people with Early Mobility and Critically Ill, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FSS-ICU (time frame: Within 24 hours of ICU discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582760, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

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