The ICU LIBERATION Study

NCT05844579 | Recruiting

• 1 other identifier: 2200115
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome (ARDS) is a condition associated with hypoxemia due to noncardiogenic causes and results in high mortality. However, the epidemiology and treatment strategy for ARDS may have changed significantly due to the accumulation of a large body of knowledge, following the two-year pandemic of the novel coronavirus (SARS-CoV-2) of which the primary manifestation is ARDS. To improve the quality of ICU care that patients receive after admission to the ICU, a variety of academic societies, including the Japanese Society of Intensive Care Medicine and the Society of Critical Care Medicine, are currently developing evidence-based guidelines and consensus guidelines and statements regarding ABCDEF bundles, nutritional therapy, ICU diary. The ABCDEF bundle, nutritional therapy, and ICU diary have been developed and are being promoted for implementation in hospitals around the world. The implementation of evidence-based ICU care is strongly recommended, especially for patients with acute respiratory distress syndrome who frequently require ventilators to maintain their lives, because their patient outcomes are worse than those who were admitted to ICU with other causes. However, there is still little evidence on how the quality of ICU care (compliance rate) correlates with patient prognosis and outcomes, and there are currently no clear goals or indicators for the ICU care we should develop. This study aims to investigate the epidemiology and treatments given to the patients and evaluate the implementation of evidence-based ICU care and its association with the outcomes of patients with acute respiratory distress syndrome admitted to the ICU. The contents of mechanical ventilation settings, respiratory conditions, and the evidence-based ICU care, such as analgesia, sedation, rehabilitation, and nutrition, given to the patients will be collected in a daily basis. Aim 1: Epidemiology Aim 2: Treatments Aim 3: Evidence-based ICU care Aim 4: ARDS related Post Intensive Care Syndrome

Conditions

Acute Respiratory Distress Syndrome; Post Intensive Care Syndrome; Treatment Compliance; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Mortality

  For Aim 1

  at the time of hospital discharge (an average of 20 days)

• Compliance of lung protective ventilation defined as Tidal Volme < 6ml/kg, Plateau Pressure < 30 cmH2O, and Driving Pressure < 15cmH2O that can be measured on the mechanical ventilator

  For Aim 2

  within the first two weeks of ICU admission

• The implementation rate of an entire and each component of the ABCDEF bundle

  For Aim 3

  within the first two weeks of ICU admission

• Incidence of Post Intensive Care Syndrome

  For Aim 4: Post Intensive Care Syndrome defined as any of the following criteria; (1) physical impairment defined as the presence of Barthel Index 90 and less, (2) cognitive impairment defined as the presence of MMSE below 24 , or (3) mental health disorders defined as the presence of HADs Anxiety 8 or higher, HADs Depression 8 or higher, or IES-R 25 or higher

  at the time of follow-up 3 months after hospital discharge

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The following Berlin definition of ARDS will be used 1. Acute onset (within 1 week of an apparent trigger or the appearance or worsening of respiratory symptoms) 2. Chest imaging (plain X-ray/CT) (pleural effusion, atelectasis, bilateral shadows that cannot be explained by nodules alone) 3. Causes of pulmonary edema (cannot be explained by cardiac insufficiency or excessive fluid infusion alone) 4. Impaired oxygenation (PEEP/CPAP ≥ 5 cmH2O and P/F ratio \< 300 mmHg)

You may qualify if:

• Patients on an invasive or non-invasive ventilator within 24 hours of ICU admission
• Patients who are expected to be on an invasive and/or non-invasive ventilator for more than 48 hours in total
• Patients who meet the diagnosis of ARDS within 24 hours of ICU admission

You may not qualify if:

• Patients who are younger than 16 years old
• Patients with terminal conditions at the time of ICU admission
• Patients who have been admitted to the ICU with a terminal care policy or who are expected to be admitted to the ICU with a terminal care policy within 24 hours of admission to the ICU
• Patients who have expressed their refusal to have their clinical data used in research.

Sponsors & Collaborators

• Japanese Society for Early Mobilization: lead

Study Sites (1)

LIBERATION Study Research Office

Tokyo, 102-0073, Japan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; postintensive care syndrome; Patient Compliance

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Kensuke Nakamura, MD, PhD

CONTACT

＋81-29-231-1111; knakamura-tky@umin.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

JP (1)