Early Mobilization in Ventilated SEpsis & Acute Respiratory Failure Study

NCT04582760 | Completed

• 2 other identifiers: 2019-11-143HC19C0226
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Early Mobility; Critically Ill

Keywords

early mobility; Sepsis; Acute respiratory failure; Intensive care unit

Outcome Measures

Primary Outcomes (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.

  Within 24 hours of ICU discharge

Secondary Outcomes (13)

• Length of ICU stay

  Within 1 month of ICU discharge

• Length of hospital stay

  Wihin 1 month of hospital discharge

• Mechanical ventilation treatment

  Within 24 hours of ICU discharge

• Delirium-free duration

  Within 24 hours of ICU discharge

• FSS-ICU

  Wihin 24 hours of hospital discharge

Study Arms (2)

early mobilization Arm

EXPERIMENTAL

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.

Other: early mobilization

non-early mobilization Arm

NO INTERVENTION

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.

Interventions

early mobilization OTHER

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.

Also known as: physical therapy

early mobilization Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Links

• outcome instruments

MeSH Terms

Conditions

Critical Illness; Sepsis

Interventions

Early Ambulation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• GeeYoung Suh, MD PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: October 12, 2020
• Study Start: September 11, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)