Early restricted oxygen therapy after resuscitation from cardiac arrest (ER-OXYTRAC): protocol for a stepped-wedge cluster randomised controlled trial
Author:
Yamamoto RyoORCID, Yamakawa KazumaORCID, Endo Akira, Homma Koichiro, Sato Yasunori, Takemura RyoORCID, Yamagiwa Takeshi, Shimizu Keiki, Kaito Daiki, Yagi Masayuki, Yonemura Taku, Shibusawa Takayuki, Suzuki GingaORCID, Shoji TakahiroORCID, Miura Naoya, Takahashi Jiro, Narita Chihiro, Kurata Saori, Minami Kazunobu, Wada Takeshi, Fujinami Yoshihisa, Tsubouchi Yohei, Natsukawa Mai, Nagayama Jun, Takayama Wataru, Ishikura Ken, Yokokawa Kyoko, Fujita Yasuo, Nakayama Hirofumi, Tokuyama Hideki, Shinada KotaORCID, Taira Takayuki, Fukui Shoki, Ushio NoritakaORCID, Nakane Masaki, Hoshiyama Eisei, Tampo Akihito, Sageshima Hisako, Takami Hiroki, Iizuka Shinichi, Kikuchi Hitoshi, Hagiwara Jun, Tagami Takashi, Funato Yumi, Sasaki Junichi, ER-OXYTRAC study group
Abstract
IntroductionCardiac 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 SpO2during the initial 12 hours after ROSC for patients with PCAS.Methods and analysisER-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 disseminationThis 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 numberUMIN Clinical Trials Registry (UMIN000046914).
Funder
specified contributions from Keio University
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