Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - Prevent 2 Study

项目摘要 呼吸机相关性肺炎（VAP）发生在接受机械通气的重症患者中 机械通气是一种严重的医院并发症，可延长住院时间，增加死亡率， 长期生活质量和认知功能。气管插管（ETT）设计的改良， 允许通过位于套囊和气囊之间的额外端口连续抽吸声门下分泌物 声带可以防止被污染的分泌物在袖带周围泄漏，从而降低 VAP。用聚氨酯（PU）代替标准聚氯乙烯（PVC）套囊材料可以 进一步防止微抽吸。我们以前成功地完成了一项随机试点对照试验， 在需要紧急插管的患者中进行两次改良ETT，以确定更大规模试验的可行性， 解决改良ETT的长期安全性和有效性。 我们提出了一项II期、随机、对照试验，将同样随机分配需要 紧急气管内插管，以接受配备持续抽吸的PU套囊ETT， 声门下分泌物（PU-CASS-ETT，n=537）或传统PVC套囊ETT（PVC-ETT，n=537）。类似于 作为初步研究，本试验将在4个成人ICU中根据知情同意例外（EFIC）进行 在俄勒冈州健康与科学大学。随机化单位为插管套件，其中包含 以隐蔽的方式，以两种适当的性别特异性 尺寸.试验的主要目的是确定PU-CASS-ETT是否与PVC-ETT一样安全，以及长期患者是否 PU-CASS-ETT组的生活质量和认知功能优于PVC-ETT组。协同主要 安全性终点是基于上气道相关并发症的安全性特征评价， 与PVC-ETT相比，在6个月后，通过面对面访谈收集喉功能障碍 随机化我们还将监测任何与器械相关的不良事件。我们的共同主要有效性终点 是生活质量，由医疗结果研究36项简式一般健康调查测量， 认知功能，由国家阿尔茨海默病协调中心的统一数据集评估，在6 随机化后3个月。次要终点包括呼吸机相关感染的发生率 相关疾病（IVAC）和呼吸机相关事件（VAE），如美国疾病控制与预防中心（CDC）定义的 对照，呼吸道抗生素使用，“临床”VAP发生率，28天无呼吸机天数，平均每日 序贯器官衰竭评估（SOFA）评分、ICU和住院时间以及死亡率（最多6人） 个月将用于评估VAP发生后产生的其他有临床意义的后果。 此外，本研究还将对生活质量进行经济学评价（成本-后果法）， 医疗资源利用和医院成本。将比较主要和次要终点 PU-CASS-ETT和PVC-ETT组之间的差异。

Project Summary Ventilator associated pneumonia (VAP) that occurs in critically ill patients who receive mechanical ventilation is a serious nosocomial complication that can prolong hospitalization, increase mortality, and reduce long term quality of life and cognitive function. Modification of the design of the endotracheal tube (ETT) that allows continuous aspiration of subglottic secretions through an extra port positioned between the cuff and the vocal cords may prevent leakage of contaminated secretions around the cuff and thereby reduce the risk of VAP. The replacement of the standard polyvinylchloride (PVC) cuff material with polyurethane (PU) may further protect from microaspiration. We previously successfully completed a randomized pilot controlled trial of two modified ETTs in patients requiring emergency intubation to establish the feasibility of a larger trial to address the long-term safety and effectiveness of modified ETTs. We propose a Phase II, randomized, controlled trial that will equally randomize patients requiring emergency endotracheal intubation to receive either a PU-cuffed ETT equipped with continuous aspiration of subglottic secretions (PU-CASS-ETT, n=537) or a conventional, PVC-cuffed ETT (PVC-ETT, n=537). Similar to the pilot study, this trial will be conducted under Exception from Informed Consent (EFIC) in the four adult ICUs at Oregon Health & Science University. The units of randomization will be the intubation kits which will contain in a concealed manner one of the two ETT models provided in duplicate in two appropriate gender-specific sizes. The trial primary aim is to determine if PU-CASS-ETT is as safe as PVC-ETT and if long-term patient quality of life and cognitive function are better in PU-CASS-ETT, compared with PVC-ETT. The co-primary safety endpoint is the evaluation of the safety profile based on upper airway-related complications and laryngeal dysfunction collected via in person interview, compared with the PVC-ETT, at 6 months after randomization. We will also monitor any device-related adverse events. Our co-primary effectiveness endpoint is quality of life, as measured by the Medical Outcomes Study 36-item Short-Form General Health Survey, and cognitive function, as assessed by the National Alzheimer Coordinating Center's Uniform Data Set, at 6 months after randomization. The secondary endpoints include the incidence of infection-related ventilator associated conditions (IVAC) and ventilator associated events (VAEs), as defined by the Center for Disease Control, respiratory antibiotics use, incidence of “clinical” VAP, 28-day ventilator-free days, mean daily Sequential Organ Failure Assessment (SOFA) score, length of ICU and hospital stay, and mortality up to six months will serve to evaluate other clinical meaningful consequences resulting from the occurrence of VAP. Furthermore, the study will perform economic evaluation (cost-consequence approach) of quality of life, healthcare resource utilization and cost for hospitals. Primary and secondary endpoints will be compared between the PU-CASS-ETT and PVC-ETT groups, using an intention-to-treat approach.