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

气管插管预防呼吸机相关肺炎的随机试验 - Prevent 2 研究

• 批准号: 10231266
• 负责人: Miriam Treggiari
• 金额: $ 79.33万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10231266
• 关键词: Address; Adult; Adult Respiratory Distress Syndrome; Adverse effects; Adverse event; Alzheimer' s Disease; Antibiotics; Bacteria; Centers for Disease Control and Prevention (U.S.); Clinical; Complication; Critical Illness; Data; Data Set; Decision Making; Devices; Effectiveness; Elements; Emergency Situation; Evaluation; Event; Extravasation; Financial Hardship; Functional disorder; Gender; Goals; Health; Health Sciences; Health Surveys; Healthcare; Hospital Costs; Hospitalization; Hour; Hypoxemia; Impaired cognition; Incidence; Infection; Inflammation; Informed Consent; Injury; Intention; Interview; Intratracheal Intubation; Intubation; Knowledge; Larynx; Length; Length of Stay; Life; Link; Long-Term Effects; Measures; Mechanical ventilation; Medical; Meta-Analysis; Modeling; Modification; Monitor; Morbidity - disease rate; Nosocomial Infections; Observational Study; Operative Surgical Procedures; Oregon; Organ failure; Outcome; Outcome Study; Patients; Persons; Phase; Physical activity; Pilot Projects; Pneumonia; Polyurethanes; Polyvinyl Chloride; Population; Positioning Attribute; Prevention; Psyche structure; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Recovery of Function; Resources; Respiratory Failure; Risk; Risk Reduction; Safety; Savings; Sepsis; Suction; Survivors; Systemic infection; Techniques; Testing; Time; Tissues; Tube; United States; Universities; Ventilator; base; burden of illness; clinical care; cognitive function; comparative effectiveness trial; cost; cost effective; dementia risk; design; economic evaluation; endotracheal; improved; mortality; neuroinflammation; patient oriented; prevent; primary endpoint; randomized trial; respiratory; risk minimization; secondary endpoint; systematic review; trial design; ventilation; ventilator-associated pneumonia; vocal cord

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.

项目摘要 呼吸机相关性肺炎(VAP)发生在接受机械治疗的危重患者 呼吸机是一种严重的医院并发症，可延长住院时间、增加死亡率和降低死亡率。 长期生活质量和认知功能。对气管插管(ETT)的设计进行了改进 允许通过位于袖带和喉罩之间的额外端口持续吸入声门下分泌物 声带可以防止受污染的分泌物在袖带周围泄漏，从而降低患上 VAP。用聚氨酯(PU)取代标准聚氯乙烯(PVC)袖带材料可能 进一步保护，防止微吸入物。我们之前成功地完成了一项随机试验对照试验 在需要紧急插管的患者中进行两项改良的ETT，以确定进行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问题。 我们提出了一项第二阶段的随机对照试验，该试验将同样随机地对需要 急诊气管插管接受带袖口的ETT并持续吸入 声门下分泌物(PU-CASS-ETT，n=537)或传统的、带PVC袖口的ETT(PVC-ETT，n=537)。类似于 这项试验性研究将在四个成人ICU的知情同意(EFIC)例外情况下进行 在俄勒冈健康与科学大学。随机化的单位将是插管工具包，它将包含 以隐蔽方式提供的两个ETT模型之一，一式两份，并按适当的性别提供 大小。试验的主要目的是确定PU-CASS-ETT是否与PVC-ETT一样安全，以及是否有长期患者 PU-CASS-ETT的生活质量和认知功能优于PVC-ETT。联合初选 安全终点是基于上呼吸道相关并发症和 6个月后通过面谈收集的喉功能障碍与PVC-ETT进行比较 随机化。我们还将监测任何与设备相关的不良事件。我们的共同初选有效性终点 生活质量是由医疗结果研究36项简式一般健康调查衡量的，以及 认知功能，由国家阿尔茨海默病协调中心的统一数据集在6岁时进行评估 在随机化之后的几个月。次要终点包括感染相关呼吸机的发生率。 疾病中心定义的相关条件(IVAC)和呼吸机相关事件(VAE) 控制、呼吸系统抗生素使用、“临床”VAP发生率、28天无呼吸机天数，平均每天 序贯器官衰竭评估(SOFA)评分、ICU和住院时间以及死亡率最高可达6 几个月将用于评估VAP发生所造成的其他临床有意义的后果。 此外，这项研究将对生活质量进行经济评估(成本-结果法)， 医院的医疗资源利用和成本。将比较主端点和次要端点 在PU-CASS-ETT组和PVC-ETT组之间，采用意向治疗方法。