Study protocol: A randomised controlled trial assessing the avoidance of endotracheal suction in cardiac surgical patients ventilated for ≤12 hours

: 目的: 评价机械通气小于等于12小时的心脏手术患者术后避免气管内吸引的安全性和疗效。 设计: 这是一项具有前瞻性、单中心、单盲、非劣性的随机对照试验,将评估机械通气小于等于12小时的无并发症的成年心脏手术患者术后避免吸入的安全性和疗效。 方法: 在患者返回重症监护室(ICU)时对其进行随机分组,分为包含吸入的常规术后护理组和不包含吸入的常规护理组(干预组)。主要结果是拔管6小时后氧分压(PaO2)与吸入氧浓度(FiO2)的比值(P/F)不同。将分别在实施气管内吸引(ETS)之前、之中和之后进行疼痛评估,并在第二天对患者的体验通过简短的访谈进行调查。本研究于2015年10月获得伦理批准。 讨论: 气管内吸引是作为气道管理的一部分实施的,但有潜在的并发症,而且没有有力的证据来指导实践。本研究将为对此患者群体实施气管内吸引的必要性和益处增加证据基础。 影响: 因为目前还没有关于避免气管内吸引的安全性的公开证据。这项研究将为供氧不足1天的患者气管内吸引的避免情况提供第一个证据。如果结果是非劣性的,其则能通过避免潜在不必要的程序来改变护理实践。这将建立在对患者体验的认识基础上。. DESIGN: A prospective, single centre, single blind, non-inferiority, randomized controlled trial evaluating the safety and efficacy of avoiding suction in uncomplicated, postoperative, adult cardiac surgical patients mechanically ventilated for ≤ 12 hr. METHODS: Randomization will be performed on return to intensive care (ICU) with allocation to either usual postoperative care including suction or to usual care with no suction (intervention arm). The primary outcome is the ratio of partial pressure of oxygen (PaO2 ) to fraction of inspired oxygen (FiO2 ) (P/F) 6 hr after extubation. Pain assessments will be performed before, during and after endotracheal suction (ETS) and the patient experience will be investigated with a brief interview the following day. Ethics approval was received in October 2015. DISCUSSION: Endotracheal suction is performed as part of airway management but has potential complications and there is little robust evidence to guide practice. This study will add to the evidence base about the need and benefit of endotracheal suction in this patient cohort. IMPACT: As there is currently no published evidence about the safety of avoiding endotracheal suction. This study will provide the first evidence about avoidance of endotracheal suction in patients ventilated for less than 1 day. If non-inferior, the results have the capacity to change nursing practice by avoiding a potentially unnecessary procedure, it will build on the body of knowledge about the patient experience.