liberation-study-summary

Study summary

【Scientific Title】

ReLatIonship BEtween implementation of evidence-based and suppoRtive ICU cAre and ouTcomes In hOspital of patieNts with Acute Respiratory Distress Syndrome ～LIBERATION Study～

【Study Design】

An international, multi-centre prospective observational study

【Introduction】

The pandemic of the COVID-19 could have changed the outcomes of and treatment strategies for the patients with ARDS.
In addition, the data on the relationship/association between the implementation of the evidence-based and supportive ICU care, such as the ABCEDF bundle, nutrition therapy, and ICU diary, and the outcomes of patients with ARDS is still insufficient instead of its high recommendation.

【Hypothesis】

  1. The outcomes of patients with ARDS have been changed/improved according to the change of treatment strategies
  2. The implementation of evidence-based ICU care are varied across the world. More frequent implementation of evidence-based and supportive ICU care could result in better outcomes for the patients with ARDS in the ICU

【Study Aims】

  1. To investigate the epidemiology of ARDS after two years of the pandemic and current treatment strategies for patients with ARDS.
  2. To investigate the implementation of evidence-based ICU care and the relationship between the implementation of evidence-based and supportive ICU care and the outcomes of ICU patients with ARDS

【Inclusions/Exclusions】

Inclusion criteria

  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
    (if the patient is in Adults or Mixed ICU)
  3. Patients who meet the diagnosis of ARDS within 24 hours of ICU admission
    (if the patient is in Pediatric ICU)
  4. Patients who meet the diagnosis of PALICC within 24 hours of ICU admission

Exclusion criteria

  1. Patients with terminal conditions at the time of ICU admission
  2. 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
  3. Patients who have expressed their refusal to have their clinical data used in research.
    ※There is a limitation in the number of patient enrolments.
    One participating ICU needs to enroll only 10 patients.

【Ethics policy】

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 that will be taken specifically for this study.
Some hospitals might require informed consent from the patients.

【Study Setting】

All ICUs could be eligible. The participating ICUs will be recruited through the local Society and other local or national networks in collaboration with regional/national coordinators. Internet services, such as Facebook, Twitter, and other mailing services will be also used for the recruitment.

【Sample Size】

We include as many patients as possible. There is no limit and no calculation in terms of sample size.
We expect 200 ICUs, equal to 2000 patients, to participate in this study.

【Patients enrol period】

01.Jun.2023 – 31.May.2024 (12 months)

【Data collection】

The background data for their hospitals and ICUs will be collected in advance.
The data to be obtained during this study are as follows.

  1. Patient characteristics
  2. Daily detailed data of the implementation of the ABCDEF bundle, nutrition, ICU diary, and other essential supportive care. The type of assessment tools, their frequency, and the score according to the use of the tool, will be also collected. For example, the type of delirium assessment tool, the frequency to use the assessment tool, and the results of positive or negative, will be obtained.
  3. Daily treatment data; mechanical ventilation and blood gas
  4. Treatmentsnts during ICU stay: ECMO, prone positioning, NMBA, CRRT, Steroid, etc.
  5. Images of X-ray or CT scanning at specific timepoints.
  6. Outcomes at the time of hospital discharge; Mortality, length of ICU and hospital stay, mechanical ventilation or ECMO period, employment, physical function (Barthel index), ambulating independency, cognitive and psychological function, and QOL
  7. 3-month follow-up after hospital discharge by a phone call: employment, physical function (Barthel index), ambulating independency, cognitive and psychological function, and QOL

Optional parameters to collect (only for participating sites where agree)

  1. Blood sample during ICU stay (ICU Day 1, 3, and 5) for proteomics analysis of ARDS
  2. Urine sample during ICU stay (ICU Day 3 and 5) for ICU-AW related protein analysis

【Incentives of the participating ICUs】

  1. All representatives of the participating ICUs will be provided with authorship (group authorship depending on the number of representatives) in the first primary paper and following all papers. They will be listed on PubMed.
  2. All representatives can submit the application form for the secondary analysis, which will be assessed by the core committee of this study.

【Incentives of the regional leaders (national cordinators).】

  1. Regional leaders will recruit as many hospitals as possible within their regions, manage the participating hospitals with close contact, monitor the data input from them, etc.
  2. All regional leaders will be listed as co-authors on the first primary paper and following all papers (could be group authorship depending on the number of authors).
  3. Regional leaders can apply for the second analysis of the registry.
  4. Regional leaders could be listed as co-authors if the hospital within the territory of the regional leader would publish a paper in case that the regional leader recruit at least 10 hospitals in their region and their data input percentage is over 90%.

【Study Research Group Organization】