【Introduction】

The pandemic of a novel coronavirus (SARS-CoV-2) has dramatically changed everything in the ICU, including treatment strategies for patients with Acute Respiratory Distress Syndrome (ARDS), ICU structure and policy, and the implementation of the evidence-based and supportive care (e.g., the ABCDEF bundle, nutrition therapy, ICU diary, physical restraint, and etc.).

However, the data regarding the epidemiology, treatments given to patients with ARDS, and the implementation of evidence-based and supportive ICU care, are significantly lacking especially in the post-COVID period.

【Survey design】

An international, multi-centre prospective observational study.

※ All ICUs, including adult, pediatric, and mixed ICUs, could be eligible to participate in this study. The ICUs, which are physically and functionally separate from each other are considered different ICUs and both ICUs can participate.

【Study aims】

This is the first study aiming to investigate the epidemiology of ARDS after the pandemic and its relationship/association between the outcomes of patients with ARDS and treatments given to them or the implementation of evidence-based ICU care (e.g., the ABCDEF bundle, nutrition therapy, ICU diary, etc.).

【Study period】

The patient enrolment period: Jun 2023 – May 2024 (12 months)

※ There is a limitation in the number of patient enrolments per participating site. One participating ICU needs to enrol only 10 consecutive patients.

【Inclusion/Exclusion criteria】

Inclusion criteria (patients who met all the criteria below will be included)

1. Patients on an invasive or non-invasive ventilator within 24 hours of ICU admission

2. Patients expected to be on an invasive and/or non-invasive ventilator for more than 48 hours

3. Patients who meet the diagnosis of ARDS within 24 hours of ICU admission

Exclusion criteria

1. Patients who are younger than 16 years old

2. Patients with terminal conditions at the time of ICU admission

3. 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

4. Patients who have expressed their refusal to have their clinical data used in research.

【Data collection methods】

All data will be entered into the Electrical Data Capture (EDC) that is specifically developed for this study and located on the could service with standard security.

The background institutional data related to their hospitals and ICUs will be collected before the study.

The following data will be collected.

1. Characteristics of patients

2. Daily detailed data of the implementation of the evidence-based and supportive ICU care for the first 14 days of ICU stay

3. Daily data of mechanical ventilation and blood gas for the first 14 days of ICU stay

4. Detailed treatments given to patients during ICU stays

5. Images of X-ray or CT scanning at specific timepoints during ICU stay (if available)

6. Outcomes at the time of ICU and hospital discharge (the outcomes will include employment status and post-intensive care syndrome (PICS) related outcomes, including QOL and physical, cognitive, and mental disfunction)

7. 3-month follow-up after hospital discharge by a phone call (if available, but highly recommend)

【Ethics】

All participants need ethical approval from their local IRB.

The informed consent will be waived because of the study nature of observational research. Furthermore, the data obtained in this study will be in the range of ordinal clinical examination and treatment, and no data will be taken specifically for this study.

However, some hospitals might require informed consent from the patients depending on the ethical policy and according to the requirement of their own IRB.

【Author-shipment】

All representatives of the participating ICUs will be provided with authorship (at least group authorship depending on the number of representatives) in the first primary paper and following all papers. Namely, they will be listed on PubMed for all papers based on this study.

【Access to data and Secondary Analysis】

All representatives of the participating ICUs can submit the application form for the secondary analysis to the research office or steering committee. The application will be appropriately assessed by the core members and the committee of this study.

【Next step for us and you】

This study will be relatively a large-scale database and create valuable evidence. The evidence based on this database could be used for the RCTs in future.

In addition, this research project will connect the researchers involved to the worldwide research network and provide you with a valuable meaning more than just a database.

【LIBERATION Study Research Office】

The Japanese Society for Early Mobilization
LIBERATION Study Steering Committee
Plarail Building, 1-2-12, Kudan-kita 1-chome, Chiyoda-ku, Tokyo 102-0073, Japan
Phone：＋81-3-3556-5585

If you have any questions, please contact the below.
E-mail:  liberation-office@googlegroups.com

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【LIBERATION Study Steering Committee】

Principle Investigator

Kensuke Nakamura, MD, PhD
Teikyo University Hospital
Department of Emergency and Critical Care Medicine
E-mail: mamashockpapashock@yahoo.co.jp

Core Research Members

Tadahiro Goto, MD, MPH
University of Tokyo
Department of Clinical Epidemiology and Health Economics, School of Public Health,
E-mail: tadahirogoto@gmail.com

Yohei Okada, MD, PhD
Kyoto University
Department of Preventive Services, Graduate School of Medicine,
E-mail: okadayohei1127@yahoo.co.jp

Shunsuke Taito, PT, PhD
Hiroshima University Hospital
Department of Clinical Practice and Support
E-mail: shutaitou@gmail.com

Hideaki Sakuramoto, RN, PhD
Japanese Red Cross Kyushu International College of Nursing
Department of Critical care and Disaster Nursing,
E-mail: gongehead@yahoo.co.jp

Keibun Liu, MD, PhD（JAPAN）
Intensive Care Collaboration Network
E-mail: keiliu0406@gmail.com

【Study Supervisor】

【Endorsing Society/Community】