Intensive care with extracorporeal membrane oxygenation rewarming in accident severe hypothermia (ICE-CRASH) study: a protocol for a multicentre prospective, observational study in Japan

Abstract

Introduction Accidental hypothermia (AH) is a rare but critical disease, leading to death in severe cases. In recent decades, extracorporeal membrane oxygenation (ECMO) has been successfully used to rewarm hypothermic patients with cardiac arrest or circulation instability. However, data on the efficacy of rewarming using ECMO for patients with AH are limited. Therefore, a large-scale, multicentre, prospective study is warranted. The primary objective of this study will be to clarify the effectiveness of rewarming using ECMO for patients with AH. Our secondary objectives will be to compare the incidence of adverse effects between ECMO rewarming and non-ECMO rewarming and to identify the most appropriate management of ECMO for AH.Methods and analyses The Intensive Care with ExtraCorporeal membrane oxygenation Rewarming in Accidentally Severe Hypothermia study is taking place in 35 tertiary emergency medical facilities in Japan. The inclusion criteria are patients ≥18 years old with a body temperature ≤32°C. We will include patients with AH who present to the emergency department from December 2019 to March 2022. The research personnel at each hospital will collect several variables, including patient demographics, rewarming method, ECMO data and complications. Our primary outcome is to compare the 28-day survival rate between the ECMO and non-ECMO (other treatments) groups among patients with severe AH. Our secondary outcomes are to compare the following values between the ECMO and non-ECMO groups: length of stay in the intensive-care unit and complications. Furthermore, in patients with cardiac arrest, the Cerebral Performance Category score at discharge will be compared between both groups.Ethics and dissemination This study received research ethics approval from Asahikawa Medical University (18194 and 19115). The study was approved by the institutional review board of each hospital, and the requirement for informed consent was waived due to the observational nature of the study.Trial registration number UMIN000036132.