Early restricted oxygen therapy after resuscitation from cardiac arrest (ER-OXYTRAC): protocol for a stepped-wedge cluster randomised controlled trial

被引：0

作者：

Yamamoto, Ryo ^{[1
]}

Yamakawa, Kazuma ^{[2
]}

Endo, Akira ^{[3
]}

Homma, Koichiro ^{[1
]}

Sato, Yasunori ^{[4
]}

Takemura, Ryo ^{[4
]}

Yamagiwa, Takeshi ^{[5
]}

Shimizu, Keiki ^{[6
]}

Kaito, Daiki ^{[1
]}

Yagi, Masayuki ^{[7
]}

Yonemura, Taku ^{[8
]}

Shibusawa, Takayuki ^{[9
]}

Suzuki, Ginga ^{[10
]}

Shoji, Takahiro ^{[11
]}

Miura, Naoya ^{[12
]}

Takahashi, Jiro ^{[13
]}

Narita, Chihiro ^{[14
]}

Kurata, Saori ^{[15
]}

Minami, Kazunobu ^{[16
]}

Wada, Takeshi ^{[17
]}

Fujinami, Yoshihisa ^{[18
]}

Tsubouchi, Yohei ^{[19
]}

Natsukawa, Mai ^{[20
]}

Nagayama, Jun ^{[21
]}

Takayama, Wataru ^{[22
]}

Ishikura, Ken ^{[23
]}

Yokokawa, Kyoko ^{[24
]}

Fujita, Yasuo ^{[25
,26
]}

Nakayama, Hirofumi ^{[27
]}

Tokuyama, Hideki ^{[28
]}

Shinada, Kota ^{[29
]}

Taira, Takayuki ^{[30
]}

Fukui, Shoki ^{[31
]}

Ushio, Noritaka ^{[2
]}

Nakane, Masaki ^{[32
]}

Hoshiyama, Eisei ^{[33
]}

Tampo, Akihito ^{[34
]}

Sageshima, Hisako ^{[35
]}

Takami, Hiroki ^{[36
]}

Iizuka, Shinichi ^{[37
]}

Kikuchi, Hitoshi ^{[38
]}

Hagiwara, Jun ^{[39
]}

Tagami, Takashi ^{[40
]}

Funato, Yumi ^{[41
]}

Sasaki, Junichi ^{[1
,42
,43
]}

Study Grp ER- OXYTRAC, Study group

机构：

[1] Keio Univ, Sch Med, Dept Emergency & Crit Care Med, Shinjuku, Tokyo, Japan

[2] Osaka Med & Pharmaceut Univ, Dept Emergency & Crit Care Med, Takatsuki, Osaka, Japan

[3] Tsuchiura Kyodo Gen Hosp, Dept Acute Crit Care Med, Tsuchiura, Ibaraki, Japan

[4] Keio Univ Hosp, Clin & Translat Res Ctr, Shinjuku, Tokyo, Japan

[5] Ebina Gen Hosp, Dept Emergency & Crit Care Med, Ebina, Kanagawa, Japan

[6] Emergency Med Ctr Tokyo Metropolitan Tama Med Ctr, Fuchuu, Tokyo, Japan

[7] Matsudo City Gen Hosp, Emergency Med & Acute Care Surg, Matsudo, Chiba, Japan

[8] Hitachi Gen Hosp, Dept Emergency & Crit Care Med, Hitachi, Ibaraki, Japan

[9] Natl Hosp Org, Tokyo Med Ctr, Dept Emergency & Crit Care Med, Meguro, Tokyo, Japan

[10] Toho Univ, Omori Med Ctr, Crit Care Ctr, Ota Ku, Tokyo, Japan

[11] Saiseikai Cent Hosp, Dept Emergency Med, Minato Ku, Tokyo, Japan

[12] Tokai Univ, Sch Med, Dept Emergency & Crit Care Med, Isehara, Kanagawa, Japan

[13] Kawasaki Med Sch, Dept Acute Med, Kurashiki, Okayama, Japan

[14] Shizuoka Prefectural Gen Hosp, Dept Emergency Med, Shizuoka, Shizuoka, Japan

[15] Saiseikai Yokohamashi Tobu Hosp, Dept Emergency & Crit Care Med, Yokohama, Kanagawa, Japan

[16] Hyogo Prefectural Nishinomiya Hosp, Emergency & Crit Care Ctr, Nishinomiya, Hyogo, Japan

[17] Hokkaido Univ, Fac Med, Dept Anesthesiol & Crit Care Med, Sapporo, Hokkaido, Japan

[18] Kakogawa Cent City Hosp, Dept Emergency Med, Kakogawa, Hyogo, Japan

[19] Subaru Hlth Insurance Soc Ota Mem Hosp, Dept Emergency & Crit Care Med, Ota, Gunma, Japan

[20] Yodogawa Christians Hosp, Dept Emergency & Crit Care Med, Osaka, Osaka, Japan

[21] Japan Red Cross Maebashi Hosp, Maebashi, Gunma, Japan

[22] Tokyo Med & Dent Univ, Hosp Med, Trauma & Acute Crit Care Ctr, Bunkyo Ku, Tokyo, Japan

[23] Mie Univ, Grad Sch Med, Dept Emergency & Disaster Med, Tsu, Mie, Japan

[24] Tohoku Univ, Grad Sch Med, Div Emergency & Crit Care Med, Sendai, Miyagi, Japan

[25] Akita Redcross Hosp, Dept Emergency, Akita, Akita, Japan

[26] Akita Redcross Hosp, Crit Care Ctr, Akita, Akita, Japan

[27] Hirosaki Univ, Sch Med, Dept Emergency & Disaster Med, Hirosaki, Aomori, Japan

[28] Fujita Med Sch Bantane Hosp, Dept Emergency & Crit Care Med, Nakagawa Ku, Nagoya, Japan

[29] Saga Univ, Dept Emergency & Crit Care Med, Saga, Saga, Japan

[30] Ryukyu Univ Hosp, Dept Emergency & Crit Care Med, Kunigamigun, Okinawa, Japan

[31] Hokkaido Univ Hosp, Dept Emergency Med, Sapporo, Hokkaido, Japan

[32] Yamagata Univ Hosp, Dept Emergency & Crit Care Med, Yamagata, Yamagata, Japan

[33] Dokkyomed Univ, Dept Neurol Emergency & Crit Care Med, Mibu, Tochigi, Japan

[34] Asahikawa City Hosp, Dept Emergency Med, Asahikawa, Hokkaido, Japan

[35] Sapporo City Gen Hosp, Dept Emergency Med, Sapporo, Hokkaido, Japan

[36] Juntendo Univ, Nerima Hosp, Dept Emergency & Crit Care Med, Nerima Ku, Tokyo, Japan

[37] Odawara Municipal Hosp, Dept Emergency & Crit Care Med, Odawara, Kanagawa, Japan

[38] Sagamihara Kyodo Hosp, Dept Emergency Med, Sagamihara, Kanagawa, Japan

[39] Nippon Med Sch, Dept Emergency & Crit Care Med, Bunkyo Ku, Tokyo, Japan

[40] Musashikosugi Hosp, Nippon Med Sch, Dept Emergency & Crit Care Med, Kawasaki, Kanagawa, Japan

[41] Natl Ctr Global Hlth & Med, Dept Emergency Med & Crit Care, Shinjuku, Tokyo, Japan

[42] Keio Univ, Sch Med, Dept Emergency & Crit Care Med, Shinjuku Ku, Tokyo, Japan

[43] Keio Univ Hosp, Shinjuku Ku, Tokyo, Japan

来源：

BMJ OPEN | 2023年 / 13卷 / 09期

关键词：

Out-of-Hospital Cardiac Arrest; Cardiopulmonary Resuscitation; Adult intensive & critical care; HYPEROXIA; ASSOCIATION; MORTALITY; METAANALYSIS; HYPOTHERMIA; GUIDELINES; OUTCOMES; ADULTS; KANTO;

D O I：

10.1136/bmjopen-2023-074475

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 (SpO(2)) 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 SpO(2 )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 SpO(2)) or the control (98%-100% of the target SpO(2)) 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.

引用

页数：11

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