Early restricted oxygen therapy after resuscitation from cardiac arrest (ER-OXYTRAC): protocol for a stepped-wedge cluster randomised controlled trial
Year: 2023
Type: article
Study design: Study Protocol
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).
Source: BMJ Open
Authors: Ryo Yamamoto, Kazuma Yamakawa, Akira Endo, Koichiro Homma, Yasunori Sato, Ryo Takemura, Takeshi Yamagiwa, Keiki Shimizu, Daiki Kaito, Masayuki Yagi, Taku Yonemura, Takayuki Shibusawa, Ginga Suzuki, Takahiro Shoji, Naoya Miura, Jiro Takahashi, Chihiro Narita, Saori Kurata, Kazunobu Minami, Takeshi Wada, Yoshihisa Fujinami, Yohei Tsubouchi, Mai Natsukawa, Jun Nagayama, Wataru Takayama, Ken Ishikura, Kyoko Yokokawa, Yasuo Fujita, Hirofumi Nakayama, Hideki Tokuyama, Kota Shinada, Takayuki Taira, Shoki Fukui, Noritaka Ushio, Masaki Nakane, Eisei Hoshiyama, Akihito Tampo, Hisako Sageshima, Hiroki Takami, Shinichi Iizuka, Hitoshi Kikuchi, Jun Hagiwara, Takashi Tagami, Yumi Funato, Junichi Sasaki, study group ER-OXYTRAC
Institutions: Keio University, Osaka Medical and Pharmaceutical University, Tsuchiura Kyodo General Hospital, Keio University Hospital, Ebina General Hospital, Tokyo Metropolitan Tama Medical Center, Matsudo City Hospital, Hitachi General Hospital, Tokyo Medical Center, National Hospital Organization, Toho University Omori Medical Center, Saiseikai Central Hospital, Tokai University, Tokai University Hospital, Kawasaki Medical School, Shizuoka General Hospital, Hyogo Prefectural Nishinomiya Hospital, Hokkaido University, Kakogawa Central City Hospital, Fuji Heavy Industries Health Insurance Society Ota Memorial Hospital, Yodogawa Christian Hospital, Maebashi Red Cross Hospital, Tokyo Medical and Dental University, Institute of Science Tokyo Hospital, Mie University, Tohoku University, Tohoku University Hospital, Akita Red Cross Hospital, Hirosaki University, Fujita Health University Bantane Hospital, Saga University, University of the Ryukyus University Hospital, Hokkaido University Hospital, Yamagata University Hospital, Dokkyo Medical University, Asahikawa City Hospital, Sapporo City General Hospital, Juntendo University, Juntendo University Nerima Hospital, Odawara Municipal Hospital, Sagamihara Kyodo Hospital, Nippon Medical School, Nippon Medical School Musashi Kosugi Hospital, National Center for Global Health and Medicine
Language: English
Subfield: Emergency Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
Funder: Keio University
OpenAlex ID: W4386768720