Abstract
INTRODUCTION: Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH. METHODS AND ANALYSES: The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature <30°C) with preserved circulation and a target sample size of 88. Patients with cardiac arrest (CA), those who have undergone hospital transfers, and those in whom a central venous catheter could not be accessed through the femoral vein will be excluded from the study. Patients will be assigned to either the endovascular catheter plus conventional rewarming group or the conventional rewarming group based on stratified-substitution block randomisation. Patients will be followed up for 30 days after the initiation of the intervention or until discharge. The primary outcome will be to compare the percentage of patients achieving a rewarming rate ≥1.5°C/hour between the endovascular catheter plus conventional rewarming group and the conventional rewarming group. ETHICS AND DISSEMINATION: This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT1012240051).