NCT04582760

Early Mobilization in Ventilated SEpsis & Acute Respiratory Failure Study

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Mobility
• Critically Ill

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-11
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2020-10-12
• Last updated: 2025-01-03

Locations

1 site across 1 country: South Korea