Pilot Trial of Tubes to Prevent VAP

描述（由申请人提供）：本初步研究的目的是为计划提供数据，并建立进行两种特殊设计的气道管（气管内管；ETTs）预防呼吸机相关性肺炎（VAP）的大型、随机、比较有效性试验的可行性。修改气管内ETT袖带的材料和设计，和/或通过位于管袖和声带之间的额外端口持续吸出声门下分泌物，可防止袖带周围污染分泌物的泄漏，从而降低VAP的风险。研究人员正在计划进行一项III期随机对照试验，比较聚氨酯套管气管内管（pu - ett）、聚氨酯套管声门下分泌物持续抽吸（pu - cass - ett）和传统聚氯乙烯套管气管内管（PVC-ETT）在机械通气呼吸衰竭患者中的有效性。在开始第三期试验之前，有必要进行一项较小的试点研究，以确定可行性，并收集终点数据，以确定最终试验的入学率和项目样本量。为了制定计划，作为VAP的替代品，气管的细菌定植将通过每日定量培养来评估，以估计两种研究装置的效应大小。次要目的包括确定这些ETT的放置是否对其他重要的临床终点有有益的影响，包括无呼吸机天数、28天死亡率、重症监护病房和住院时间，并通过评估ETT取出后持续存在的上呼吸道并发症来确定设备的安全性。大约90名在院内或院外接受紧急气管插管的危重病人将被随机分配接受三种气管插管中的一种。VAP将根据支气管肺泡灌洗培养的客观标准进行诊断。我们将采用多方面的方法对导管的安全性进行评估，包括短期客观的喉功能障碍测量，出院后通过电话访谈对上呼吸道问题进行长期主观和客观的评估，并记录与设备相关的不良事件。

DESCRIPTION (provided by applicant): The objective of this pilot study is provide data for planning and to establish the feasibility of performing a large, randomized, comparative effectiveness trial of two specially designed airway tubes (endotracheal tubes; ETTs) for the prevention of ventilator-associated pneumonia (VAP). Modification of the material and design of the ETT cuff that is positioned in the trachea, and/or continuous aspiration of subglottic secretions through an extra port positioned between the tube cuff and the vocal chords may prevent leakage of contaminated secretions around the cuff and thereby reduce the risk of VAP. The investigators are planning a phase III, randomized, controlled trial comparing the effectiveness of a polyurethane-cuffed endotracheal tube (PUC-ETT), a polyurethane-cuffed tube that also allows continuous aspiration of subglottic secretions (PUC-CASS-ETT), and a conventional, polyvinylchloride-cuffed endotracheal tube (PVC-ETT) in mechanically ventilated patients with respiratory failure. Prior to initiating the Phase III trial, a smaller pilot study is necessary in order to establish feasibility and to gather data on endpoints in order to establish enrollment rates and project sample size for the definitive trial. For the purposes of planning, a surrogate for VAP, bacterial colonization of the trachea will be assessed from daily quantitative cultures to allow estimation of effect size for the two study devices. Secondary aims include the determination of whether the placement of these ETTs has beneficial effects on other important clinical endpoints, including ventilator-free days, 28-day mortality, intensive care unit and hospital length of stay, and to determine the safety profile of the devices by assessment of upper airway complications persisting after removal of the ETT. Approximately 90 critically ill patients undergoing emergency tracheal intubation in- or out-of-hospital will be randomized to receive one of the three ETTs. VAP will be diagnosed using objective criteria, based on cultures from bronchoalveolar lavage. The safety profile of the tubes will be evaluated using a multi-faceted approach, including short-term objective measures of laryngeal dysfunction and long-term subjective and objective assessment of upper airway problems via phone interview post-hospital discharge, and recording of device-related adverse events.