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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

项目概要呼吸机相关性肺炎 (VAP) 发生于接受机械治疗的危重患者通气是一种严重的院内并发症，可延长住院时间、增加死亡率并减少长期生活质量和认知功能的修改气管插管（ETT）的设计。允许通过袖带和袖带之间的额外端口连续抽吸声门下分泌物声带可以防止袖带周围受污染的分泌物泄漏，从而降低感染的风险 VAP。可以用聚氨酯 (PU) 替代标准聚氯乙烯 (PVC) 袖带材料。我们之前成功完成了一项随机试点对照试验。对需要紧急插管的患者进行两次改良的 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。我们提议进行一项 II 期随机对照试验，该试验将同样随机化需要治疗的患者紧急气管插管，用于接受配备连续抽吸功能的 PU 套囊 ETT 声门下分泌物（PU-CASS-ETT，n=537）或传统的 PVC 套囊 ETT（PVC-ETT，n=537）。试点研究，该试验将在知情同意例外 (EFIC) 的情况下在四个成人 ICU 中进行在俄勒冈健康与科学大学，随机化的单位将是插管套件，其中包含以隐藏的方式在两个适当的性别特定中一式两份提供两个 ETT 模型之一该试验的主要目的是确定 PU-CASS-ETT 是否与 PVC-ETT 一样安全，以及是否可以长期接受治疗。与 PVC-ETT 相比，PU-CASS-ETT 的生活质量和认知功能更好。安全终点是根据上呼吸道相关并发症对安全状况进行评估与 PVC-ETT 相比，术后 6 个月通过亲自访谈收集的喉功能障碍我们还将监测任何与设备相关的不良事件。是通过医疗结果研究 36 项简短一般健康调查衡量的生活质量，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评估，6 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病症 (IVAC) 和呼吸机相关事件 (VAE) 控制、呼吸道抗生素的使用、“临床”VAP 的发生率、28 天不使用呼吸机的天数、平均每天序贯器官衰竭评估 (SOFA) 评分、ICU 和住院时间以及最高 6 岁的死亡率几个月将用于评估 VAP 发生导致的其他有临床意义的后果。此外，该研究将对生活质量进行经济评估（成本后果法），将比较医院的医疗保健资源利用率和成本。 PU-CASS-ETT 和 PVC-ETT 组之间采用意向治疗方法。