ISIIC Study

【Introduction】

Strict infection control and the imbalance between resources and the increase in the number of patients with COVID-19 may prevent us from incorporating daily ICU daily care which is generally recommended such as the ABCDEF bundle, PADIS guideline, and nutrition, into clinical practice.

【Survey design】

An international, prospective, multi-center, questionnaire-based two-day prevalence survey.

All hospitals / ICUs can register to participate in this online study. All participating centers will be asked if they have laboratory-confirmed COVID-19 patients at the survey time. If yes, then you may fill out the questionnaire. There are no exclusion criteria in terms of enrolling centers.

【Survey dates】

3rd June  and  1st July

【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 patients with COVID-19 on the survey dates. 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 (3rd June or 1st July). The URL will expire at 8:00 am on 5th June, if the survey date is 3rd June, or 3rd July, if the survey date is 1st July. It will take 5-10 minutes to complete the online form for the hospital and ICU data. It will take 5-10 minutes to complete the online form for ICU daily care for each patient with COVID-19 on the survey date.

【Ethics】

This study is 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: https://forms.gle/sLhV2EGPuZE5W2jt6

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 name of the representative from each facility will be included in the acknowledgments of the primary paper.

【ISIIC Study Committee and Project Office】

The Japanese Society of Intensive Care Medicine
Committee and Working Group on PICS Measures and Quality of Life
ISIIC Study Committee
Tokyo building 8F, 3-32-7, Hongou, Bunkyo-ku, Tokyo, 113-0033
TEL: +81-3-3815-0589

If you have any questions, please contact the below.
E-mail from Japan: pics-covid-j@jsicm.org
Email from non-Japanese countries: pics-covid-e@jsicm.org

【Chief Investigator】

Keibun Liu, M.D., Ph.D.
Saiseikai Utsunomiya Hospital
Department of Emergency and Critical Care Medicine
The Prince Charles Hospital
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

Osamu Nishida, M.D., Ph.D.
Fujita Health University School of Medicine
Department of Anesthesiology and Critical Care Medicine
The president of the Japanese Society of Intensive Care Medicine

【Research Advisor】

Peter Nydahl
University Hospital of Schleswig-Holstein, Germany

E Wesley Ely
Geriatric Research, Education and Clinical Center, Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, US

Sapna R Kudchadkar
Johns Hopkins University School of Medicine, US

Alan Kawarai Lefor
Jichi Medical University, Japan