【Introduction】
The COVID-19 pandemic has drastically changed our ICU practice in all aspects. Strict infection control and the imbalance between resources and demand in response to the increase in the number of patients with COVID-19 may prevent us from incorporating evidence based ICU daily care into clinical practice which is generally recommended to perform for all ICU patients, such as the ABCDEF bundle, PADIS guideline, and nutrition.
【Survey design】
An international, prospective, multi-center, questionnaire-based two-day prevalence survey.
All hospitals / ICUs from Asia, Europe, and Africa can register to participate in this online study. The data from hospitals in the area of the United States and Oceania may be excluded from this study analysis because of regional issues.
【Survey dates】
27th January,2021
【Data collection methods】
Representatives from participating sites will receive two URLs to access the online questionnaire and follow the instructions. One URL is for collection of data related to the hospital and ICU characteristics. The other URL is for collection of data related to implementation of daily ICU care for all ICU patients, regardless of COVID-19 or not, on the survey date. The participant would complete the online questionnaire in coordination with other ICU staff. The questionnaire will not include any information which could identify the participating hospital / ICU or patients. Participants must respond within 48 hours from 8:00 am on the survey date (27th January, 2021). The URL will expire at 8:00 am on 29th January, 2021.
It will take 3-5 minutes to complete the online form for the hospital and ICU data.
It will take 3-5 minutes to complete the online form for ICU daily care for each ICU patient on the survey date.
【Ethics】
This study was approved by the Institutional Review Board in the central research institution (Saiseikai Utsunomiya Hospital, Japan) . The ISIIC Study Committee believes that ethical review in each facility is not mandatory according to the ethical policy in Japan. This study is in line with the declaration of Helsinki and will be conducted via a survey that does not include personal information as defined in the Personal Information Protection Law in Japan, and therefore judged to meet the requirements of the ethics review exemption in the ethical guidelines for medical research as described below.
(1) The collected information does not include data that can be used to identify the facility or individual.
(2) We do not use samples taken from the human body.
(3) This is an observational study that does not involve any intervention or any burden on the personnel.
(4) The registered institutions definitely have the right to decide whether they choose to answer the questions.
(5) The content of the questions will not cause psychological distress to the questionnaire respondents. Questionnaire respondents in registered facilities are guaranteed the right to refuse to answer the questionnaire and are not disadvantaged or coerced into answering the questionnaire if they do not return it.
Each institution outside of Japan must consider the necessity of ethical review in their location. If you have any questions regarding the need for ethical review, contact the ISIIC Study Committee or the ethics committee at our institutions.
【Registration to this survey】
URL for registration from outside of Japan: https://forms.gle/sUJfLDpYoJ9nHDZr7
URL for registration from Japan: https://forms.gle/kbxoBqNA3RXjm7qb6
Please access the above URL and register your information and e-mail address. The study website address will be sent to the registered e-mail address.
【Data Management】
All collected data is anonymized and cannot be linked to each participating hospital or individual patient under the study policy and guideline of the Ministry of Health, Labor and Welfare in Japan. The online form and its data is made and managed by TXP Medical (Japan) with appropriate data security.
【Access to data and Secondary Analysis】
Anyone who want to access the data can obtain the data in EXCEL format with permission of ISIIC study Committee, after the primary study paper is published. Representatives from the participating sites will have priority for data access, rather than others who did not participate in this study.
【Acknowledgments】
The registered name of the representative from each facility, even from the United States and Oceania, will be included in the acknowledgments of the primary paper.
【ISIIC 2 Study Committee and Project Office】
ISIIC 2 Study Committee
Level 2, 1-2-12, Kudankita, Chiyoda-ku, Tokyo, 102-0073
TEL: +81-3-3556-5585
If you have any questions, please contact the below.
E-mail: isiic2@jsea2005.org
【Chief Investigator】
Keibun Liu, M.D., Ph.D.
The Prince Charles Hospital
Critical Care Research Group
E-mail: keiliu0406@gmail.com
Kensuke Nakamura, M.D., Ph.D.
Hitachi General Hospital
Department of Emergency and Critical Care Medicine
E-mail:mamashockpapashock@yahoo.co.jp
Hajime Katsukawa , PT , Ph.D.
Japanese Society for Early Mobilization
Shigeaki Inoue, MD, PhD, MSCI
Emergency and Critical Care Center, Kobe University Hospital
Department of Disaster and Emergency Medicine, Kobe University, Graduate School of Medicine
Osamu Nishida, M.D., Ph.D.
Fujita Health University School of Medicine
Department of Anesthesiology and Critical Care Medicine
【Overseas Collaborators】
Eugene Wesley Ely, MD, MPH
1Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center
Vanderbilt University School of Medicine, Nashville, TN, USA
2Geriatric Research Education and Clinical Center (GRECC),
Department of Veterans Affairs Medical Center,
Tennessee Valley Healthcare System, Nashville, TN, USA.
Sapna R Kudchadkar, MD, PhD
Department of Anesthesiology and Critical Care Medicine
Department of Physical Medicine and Rehabilitation, and Department of Pediatrics,
Johns Hopkins University School of Medicine, Baltimore, USA
Peter Nydahl ,RN,Ph.D.
University Hospital of Schleswig-Holstein, Kiel, Germany
Department of Anesthesiology and Intensive Care Medicine
Muhammed Elhadi, MBBCh
University of Tripoli, Tripoli, Libya
Faculty of Medicine,