{
  "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).",
  "authors": [
    {
      "affiliations": [
        "Department of Emergency Medicine, Hokkaido University Hospital, Sapporo, Japan"
      ],
      "name": "Shuhei Takauji"
    },
    {
      "affiliations": [
        "Department of Emergency and General Medicine, Sapporo City General Hospital, Sapporo, Japan"
      ],
      "name": "Mineji Hayakawa"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Nippon Medical School, Bunkyo, Japan"
      ],
      "name": "Shoji Yokobori"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Nippon Medical School, Bunkyo, Japan"
      ],
      "name": "Hitoshi Kano"
    },
    {
      "affiliations": [
        "Department of Critical Care and Emergency Medicine, Tokyo Metropolitan Tama Medical Center, Fuchu, Japan"
      ],
      "name": "Keiki Shimizu"
    },
    {
      "affiliations": [
        "Department of Critical Care and Emergency Medicine, Tokyo Metropolitan Tama Medical Center, Fuchu, Japan"
      ],
      "name": "Yuichi Horikoshi"
    },
    {
      "affiliations": [
        "Medical Emergency Center, Kansai Medical University Medical Center, Moriguchi, Japan"
      ],
      "name": "Junya Shimazaki"
    },
    {
      "affiliations": [
        "Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine Faculty of Medicine, Suita, Japan"
      ],
      "name": "Jotaro Tachino"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Hyogo Emergency Medical Center, Kobe, Japan"
      ],
      "name": "Akihiko Inoue"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Hyogo Emergency Medical Center, Kobe, Japan"
      ],
      "name": "Taiki Moriyama"
    },
    {
      "affiliations": [
        "Senri Critical Care Medical Center, Osaka Saiseikai Senri Hospital, Osaka, Japan"
      ],
      "name": "Hirotaka Sawano"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Nara Medical University, Kashihara, Japan"
      ],
      "name": "Hidetada Fukushima"
    },
    {
      "affiliations": [
        "Department of Emergency, Disaster and General Medicine, Hirosaki University, Hirosaki, Japan"
      ],
      "name": "Kana Sugiyama"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Nayoro City General Hospital, Nayoro, Japan"
      ],
      "name": "Daiki Sunada"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Kushiro City General Hospital, Kushiro, Japan"
      ],
      "name": "Takashi Toyohara"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Sapporo Medical University, Sapporo, Japan"
      ],
      "name": "Keigo Sawamoto"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, St Luke’s International Hospital, Tokyo, Japan"
      ],
      "name": "Shutaro Isokawa"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Japan"
      ],
      "name": "Miki Morikawa"
    },
    {
      "affiliations": [
        "Toho University Omori Medical Center, Tokyo, Japan"
      ],
      "name": "Ginga Suzuki"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Japanese Red Cross Akita Hospital, Akita, Japan"
      ],
      "name": "Noriyuki Omura"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Yodogawa Christian Hospital, Osaka, Japan"
      ],
      "name": "Kazunari Takeda"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, St Mary’s Hospital, Kurume, Japan"
      ],
      "name": "Tomohiro Inoue"
    },
    {
      "affiliations": [
        "Emergency and Critical Care Medical Center, Kishiwada Tokushukai Hospital, Kishiwada, Japan"
      ],
      "name": "Tian Tian"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Kansai Medical University, Hirakata, Japan"
      ],
      "name": "Fumiko Nakamura"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Kansai Medical University, Hirakata, Japan"
      ],
      "name": "Yoshihiro Nakamura"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Hiratsuka City Hospital, Hiratsuka, Japan"
      ],
      "name": "Yukitoshi Toyoda"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Asahikawa City Hospital, Asahikawa, Japan"
      ],
      "name": "Akihito Tampo"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine and Critical Care Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan"
      ],
      "name": "Yoshihiro Hagiwara"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Tohoku University Hospital, Sendai, Japan"
      ],
      "name": "Daisuke Kudo"
    },
    {
      "affiliations": [
        "Department of Emergency and Critical Care Medicine, Tohoku University Hospital, Sendai, Japan"
      ],
      "name": "Norihiro Miyasaka"
    },
    {
      "affiliations": [
        "Department of Intensive Care, Chiba Emergency and Psychiatric Medical Center, Chiba, Japan"
      ],
      "name": "Tomohiro Morito"
    },
    {
      "affiliations": [
        "Tottori Emergency and Critical Care Medical Center, Tottori Prefectural Central Hospital, Tottori, Japan"
      ],
      "name": "Makoto Kobayashi"
    },
    {
      "affiliations": [
        "Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Japan"
      ],
      "name": "Kazuto Ohtaka"
    },
    {
      "affiliations": [
        "Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, Sapporo, Japan"
      ],
      "name": "Yusuke Watanabe"
    },
    {
      "affiliations": [
        "Katakura Hospital, Ube, Japan"
      ],
      "name": "Tsuyoshi Maekawa"
    },
    {
      "affiliations": [
        "Department of Emergency Medicine, Hokkaido University Hospital, Sapporo, Japan"
      ],
      "name": "Takeshi Wada"
    },
    {
      "affiliations": [],
      "name": "study group ICE-CRASH II"
    }
  ],
  "title": "Intensive care with endovascular catheter rewarming for accidental severe hypothermia (ICE-CRASH II): a protocol for a randomised controlled study",
  "uid": "8c083eb2-a4fe-550c-9460-1facc52fe82d"
}