McCabe C J, Browne B J
Am J Emerg Med. 1986 Jan;4(1):64-71. doi: 10.1016/0735-6757(86)90254-8.
Prior to approval of the EOA, this device had not been documented to be effective in oxygenation and ventilation in the pre-hospital arena. The studies quoted to demonstrate its usefulness were done in the very controlled environment of the operating room or of the emergency department. Indeed, the studies on blood gases obtained immediately upon entry into the emergency department would indicate that the esophageal obturator airway is an inadequate and ineffectual pre-hospital airway. The ability of the device to obstruct the esophagus, has been questioned. In a recent review of the EOA, Smith et al state that "How the EOA gained widespread popularity for use in patients requiring CPR without any evidence of its effectiveness is worthy of investigation". The Food and Drug Administration "grandfathered" the EOA as an acceptable device. This approval was to be reviewed with time, and if complications were reported, a second evaluation of the esophageal obturator airway was to be undertaken. Unfortunately, this has never occurred. We are now faced with the pharyngeal-tracheal lumen airway, which is being marketed for use in the pre-hospital area. The Food and Drug Administration approved the marketing and use of this device based on its similarity to the esophageal obturator airway. The PTL, is a device in many respects similar to the EOA. It has been tested in the operating room and the emergency department. In a study done on unsuccessfully resuscitated patients, it was as effective as an ETT. However, no study has shown that the PTL can be used successfully in the pre-hospital setting by ambulance personnel.(ABSTRACT TRUNCATED AT 250 WORDS)
在食管阻塞气道(EOA)获批之前,尚无文献证明该设备在院前环境中用于氧合和通气方面有效。所引用的用以证明其有用性的研究是在手术室或急诊科等非常可控的环境中进行的。实际上,对进入急诊科后立即采集的血气分析研究表明,食管阻塞气道在院前作为气道工具是不足且无效的。该设备阻塞食管的能力也受到了质疑。在最近对EOA的综述中,史密斯等人指出,“EOA在没有任何有效性证据的情况下,如何在需要心肺复苏的患者中广泛流行,值得调查”。美国食品药品监督管理局(FDA)将EOA作为可接受的设备给予了“祖父条款”豁免批准。该批准将随着时间推移进行审查,如果报告了并发症,将对食管阻塞气道进行二次评估。不幸的是,这种情况从未发生过。我们现在面临着咽喉气管腔气道,该气道正在面向院前领域进行推广销售。FDA基于其与食管阻塞气道的相似性,批准了该设备的销售和使用。咽喉气管腔气道在很多方面与EOA类似。它已在手术室和急诊科进行了测试。在一项针对复苏失败患者的研究中,它与气管内插管(ETT)的效果相当。然而,尚无研究表明咽喉气管腔气道能被救护人员成功应用于院前环境。(摘要截选至250词)