2018-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/711291摘要:社區猝死病患 (out-of-hospital cardiac arrest; OHCA) 的急救,是緊急醫療救護最重要的課題之一。而釐清社區猝死病患到院前不同進階呼吸道處置對病患預後的影響,則是全世界緊急醫療救護系統進步的城市,目前最關注的科學議題;面對回溯性研究眾說紛云的結果, 隨機對照臨床試驗是拍板定案最重要的方式。本計畫為三年期的連續計畫,目標是針對社區猝死病患、比較高級救護技術員所使用的兩種進階呼吸道:聲門上呼吸道與氣管內管,對病患存活預後的影響,進行隨機對照研究。又定名為「拯救試驗」 (SAVE trial: Supraglottic Airway VersusEndotracheal tub )。本研究之假說 (P-I-C-O 格式) 為:台北市社區之中成人非創傷猝死病患經由高級救護員技術員進行急救者(P),接受氣管內管插管治療組(I),比起接受聲門上呼吸道治療組(C),有較好的持續性自發性心跳回復率及長期存活率(O)。參考台北市過去經驗院外猝死經由高級救護員作呼吸道處置數量的背景值,樣本數估計需有852 位收案對象、費時34個月(二年十個月) 方能達成。本主題深受緊急救護及急救醫學界的關注,本研究「拯救試驗」又是隨機對照設計,故結果一定能有高水準的期刊論文發表,提昇我國緊急醫療救護在國際上之能見度,也能以華人族群的結果觀點,為緊急救護及急救醫學貢獻新知,進而改善社區猝死病患的存活預後。<br> Abstract: Overall survival of patients after out-of-hospital cardiac arrest (OHCA) is less than 10%worldwide. Interventions provided by emergency medical system (EMS) before arrival at hospitalare of paramount importance to patient outcomes after OHCA. Among those interventions, thepros-and-cons of different prehospital advanced airways, including supraglottic airway (SGA) orendotracheal tube (ETT), remained the issue of most under debate. The objective of this study is todetermine the comparative effective of ETT vs SGA after OHCA by conducting a randomizedcontrolled trial (RCT) in Taipei EMS.In this 3-year successive research plan, we will conduct a prehospital randomized controlledtrial to address the following question (in P-I-C-O style): In adult patients with non-traumatic causeof OHCA resuscitated by emergency medical technician paramedic (EMTP) in the prehospitalsetting, will receiving endotracheal tube (ETT) intubation cause a better chance of sustainedrecovery of spontaneous circulation and other survival outcomes like neurologically favorablestatus, comparing to those who receiving supraglottic airway (SGA) device. To name in short, wecalled it a “SAVE trial” standing for Supraglottic Airway Versus Endotracheal tube.According to the previous literature, background data, and previous experience in conductingthe very first prehospital RCT in Taiwan and Asia by our research team, we estimated the samplesize as 852 patients of OHCA to detect the primary outcome difference, and will take a 34-monthperiod to complete the enrollment. As we know, conducting a RCT especially in the prehospitalsetting is a pain-taking, time-consuming task but it is also a must-be-done to answer the mostimportant question in the prehospital airway management by EMTP for patients with OHCAs.Expected results from this “SAVE trial” can figure out the best strategy of prehospitaladvanced airway in our own and worldwide EMS with similar configuration, therefore find out thepromising chance to improve outcomes of patients with OHCA.緊急醫療救護呼吸道處置進階呼吸道到院前心肺停止氣管插管聲門上呼吸道Emergency Medical ServiceAirway ManagementAdvanced AirwayOut-of-Hospital Cardiac ArrestEndotracheal TubeSupraglottic AirwayA Randomized Controlled Trial of the Clinical Outcomes of Supraglottic Airway Divice Versus Endotracheal Intubation in the Prehospital Airway Management of Patients with Out-Of-Hospital Cardiac Arrest (Save Trial)=社區心跳停止病患之到院前進階呼吸道隨機對照研究