BMJ Open (Sep 2023)
Early restricted oxygen therapy after resuscitation from cardiac arrest (ER-OXYTRAC): protocol for a stepped-wedge cluster randomised controlled trial
- Kazuma Yamakawa,
- Yasunori Sato,
- Takashi Tagami,
- Akira Endo,
- Hirofumi Nakayama,
- Takeshi Wada,
- Masayuki Yagi,
- Takeshi Yamagiwa,
- Shinichi Iizuka,
- Daiki Kaito,
- Naoya Miura,
- Ryo Takemura,
- Kota Shinada,
- Ginga Suzuki,
- Keiki Shimizu,
- Eisei Hoshiyama,
- Saori Kurata,
- Ryo Yamamoto,
- Koichiro Homma,
- Taku Yonemura,
- Takayuki Shibusawa,
- Takahiro Shoji,
- Jiro Takahashi,
- Chihiro Narita,
- Kazunobu Minami,
- Yoshihisa Fujinami,
- Yohei Tsubouchi,
- Mai Natsukawa,
- Jun Nagayama,
- Wataru Takayama,
- Ken Ishikura,
- Kyoko Yokokawa,
- Yasuo Fujita,
- Hideki Tokuyama,
- Takayuki Taira,
- Shoki Fukui,
- Noritaka Ushio,
- Masaki Nakane,
- Akihito Tampo,
- Hisako Sageshima,
- Hiroki Takami,
- Hitoshi Kikuchi,
- Jun Hagiwara,
- Yumi Funato,
- Junichi Sasaki,
- study group ER-OXYTRAC
Affiliations
- Kazuma Yamakawa
- Department of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan
- Yasunori Sato
- Clinical and Translational Research Center, Keio University Hospital, Shinjuku, Tokyo, Japan
- Takashi Tagami
- Department of Emergency and Critical Care Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Kanagawa, Japan
- Akira Endo
- Department of Acute Critical Care Medicine, Tsuchiura Kyodo General Hospital, Tsuchiura, Ibaraki, Japan
- Hirofumi Nakayama
- Department of Emergency and Disaster Medicine, Hirosaki University School of Medicine, Hirosaki, Aomori, Japan
- Takeshi Wada
- Department of Anesthesiology and Critical Care Medicine, Hokkaido University Faculty of Medicine, Sapporo, Hokkaido, Japan
- Masayuki Yagi
- Emergency Medicine and Acute Care Surgery, Matsudo City General Hospital, Matsudo, Chiba, Japan
- Takeshi Yamagiwa
- Department of Emergency and Critical Care Medicine, Ebina General Hospital, Ebina, Kanagawa, Japan
- Shinichi Iizuka
- Department of Emergency and Critical Care Medicine, Odawara Municipal Hospital, Odawara, Kanagawa, Japan
- Daiki Kaito
- Department of Emergency and Critical Care Medicine, Keio University School of Medicine, Shinjuku, Tokyo, Japan
- Naoya Miura
- Department of Emergency and Critical Care Medicine, Tokai University School of Medicine, Isehara, Kanagawa, Japan
- Ryo Takemura
- Clinical and Translational Research Center, Keio University Hospital, Shinjuku, Tokyo, Japan
- Kota Shinada
- Department of Emergency and Critical Care Medicine, Saga University, Saga City, Saga, Japan
- Ginga Suzuki
- Critical Care Center, Toho University Omori Medical Center, Ota-ku, Tokyo, Japan
- Keiki Shimizu
- Emergency Medical Center of Tokyo Metropolitan Tama Medical Center, Fuchuu, Tokyo, Japan
- Eisei Hoshiyama
- Department of Neurology/Emergency and Critical Care Medicine, Dokkyomedical University, Mibu, Tochigi, Japan
- Saori Kurata
- Department of Emergency and Critical Care Medicine, Saiseikai Yokohamashi Tobu Hospital, Yokohama, Kanagawa, Japan
- Ryo Yamamoto
- Department of Emergency and Critical Care Medicine, Keio University School of Medicine, Shinjuku, Tokyo, Japan
- Koichiro Homma
- Department of Emergency and Critical Care Medicine, Keio University School of Medicine, Shinjuku, Tokyo, Japan
- Taku Yonemura
- Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan
- Takayuki Shibusawa
- Department of Emergency and Critical Care Medicine, National Hospital Organization Tokyo Medical Center, Meguro, Tokyo, Japan
- Takahiro Shoji
- Department of Emergency Medicine, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan
- Jiro Takahashi
- Department of Acute Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan
- Chihiro Narita
- Department of Emergency Medicine, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan
- Kazunobu Minami
- Emergency and Critical Care Center, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya City, Hyogo, Japan
- Yoshihisa Fujinami
- Department of Emergency Medicine, Kakogawa Central City Hospital, Kakogawa, Hyogo, Japan
- Yohei Tsubouchi
- Department of Emergency and Critical Care Medicine, Subaru Health Insurance Society Ota Memorial Hospital, Ota City, Gunma, Japan
- Mai Natsukawa
- Department of Emergency and Critical Care Medicine, Yodogawa Christian Hospital, Osaka City, Osaka, Japan
- Jun Nagayama
- Japan Red Cross Maebashi Hospital, Maebashi, Gunma, Japan
- Wataru Takayama
- Trauma and Acute Critical Care Center, Tokyo Medical and Dental University Hospital of Medicine, Bunkyo-ku, Tokyo, Japan
- Ken Ishikura
- Department of Emergency and Disaster Medicine, Mie University Graduate School of Medicine, Tsu City, Mie, Japan
- Kyoko Yokokawa
- Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine, Tohoku University Hospital Emergency Center, Sendai, Miyagi, Japan
- Yasuo Fujita
- Department of Emergency and Critical Care Center, Akita Redcross Hospital, Akita City, Akita, Japan
- Hideki Tokuyama
- Department of Emergency and Critical Care Medicine, Fujita Medical School Bantane Hospital, Nakagawa-ku, Nagoya, Japan
- Takayuki Taira
- Department of Emergency and Critical Care Medicine, Ryukyu University hospital, Kunigamigun, Okinawa, Japan
- Shoki Fukui
- Department of Emergency Medicine, Hokkaido University Hospital, Sapporo, Hokkaido, Japan
- Noritaka Ushio
- Department of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan
- Masaki Nakane
- Department of Emergency and Critical Care Medicine, Yamagata University Hospital, Yamagata City, Yamagata, Japan
- Akihito Tampo
- Department of Emergency Medicine, Asahikawa City Hospital, Asahikawa, Hokkaido, Japan
- Hisako Sageshima
- Department of Emergency Medicine, Sapporo City General Hospital, Sapporo, Hokkaido, Japan
- Hiroki Takami
- Department of Emergency and Critical Care Medicine, Juntendo University Nerima Hospital, Nerima-ku, Tokyo, Japan
- Hitoshi Kikuchi
- Department of Emergency Medicine, Sagamihara Kyodo Hospital, Sagamihara City, Kanagawa, Japan
- Jun Hagiwara
- Department of Emergency and Critical Care Medicine, Nippon Medical School, Bunkyo-ku, Tokyo, Japan
- Yumi Funato
- Department of Emergency Medicine and Critical Care, National Center for Global Health and Medicine, Shinjuku, Tokyo, Japan
- Junichi Sasaki
- Department of Emergency and Critical Care Medicine, Keio University School of Medicine, Shinjuku, Tokyo, Japan
- study group ER-OXYTRAC
- Japanese Association for Acute Medicine, Tokyo, Japan
- DOI
- https://doi.org/10.1136/bmjopen-2023-074475
- Journal volume & issue
-
Vol. 13,
no. 9
Abstract
Introduction Cardiac arrest is a critical condition, and patients often experience postcardiac arrest syndrome (PCAS) even after the return of spontaneous circulation (ROSC). Administering a restricted amount of oxygen in the early phase after ROSC has been suggested as a potential therapy for PCAS; however, the optimal target for arterial partial pressure of oxygen or peripheral oxygen saturation (SpO2) to safely and effectively reduce oxygen remains unclear. Therefore, we aimed to validate the efficacy of restricted oxygen treatment with 94%–95% of the target SpO2 during the initial 12 hours after ROSC for patients with PCAS.Methods and analysis ER-OXYTRAC (early restricted oxygen therapy after resuscitation from cardiac arrest) is a nationwide, multicentre, pragmatic, single-blind, stepped-wedge cluster randomised controlled trial targeting cases of non-traumatic cardiac arrest. This study includes adult patients with out-of-hospital or in-hospital cardiac arrest who achieved ROSC in 39 tertiary centres across Japan, with a target sample size of 1000. Patients whose circulation has returned before hospital arrival and those with cardiac arrest due to intracranial disease or intoxication are excluded. Study participants are assigned to either the restricted oxygen (titration of a fraction of inspired oxygen with 94%–95% of the target SpO2) or the control (98%–100% of the target SpO2) group based on cluster randomisation per institution. The trial intervention continues until 12 hours after ROSC. Other treatments for PCAS, including oxygen administration later than 12 hours, can be determined by the treating physicians. The primary outcome is favourable neurological function, defined as cerebral performance category 1–2 at 90 days after ROSC, to be compared using an intention-to-treat analysis.Ethics and dissemination This study has been approved by the Institutional Review Board at Keio University School of Medicine (approval number: 20211106). Written informed consent will be obtained from all participants or their legal representatives. Results will be disseminated via publications and presentations.Trial registration number UMIN Clinical Trials Registry (UMIN000046914).
