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Intensive care with endovascular catheter rewarming for accidental severe hypothermia (ICE-CRASH II): a protocol for a randomised controlled study

Por: Takauji · S. · Hayakawa · M. · Yokobori · S. · Kano · H. · Shimizu · K. · Horikoshi · Y. · Shimazaki · J. · Tachino · J. · Inoue · A. · Moriyama · T. · Sawano · H. · Fukushima · H. · Sugiyama · K. · Sunada · D. · Toyohara · T. · Sawamoto · K. · Isokawa · S. · Morikawa · M. · Suzuki · G. · Om
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

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).

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