Pilot Trial of Tubes to Prevent VAP

预防 VAP 的管材试点试验

• 批准号: 8191350
• 负责人: STEVEN A DEEM
• 金额: $ 34.44万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8191350
• 关键词: Acute respiratory failure; Adverse event; Bacteria; Bacterial Pneumonia; Bronchoalveolar Lavage; Clinical; Clinical Trials Design; Confidence Intervals; Critical Illness; Data; Data Collection; Development; Devices; Diagnosis; Effectiveness of Interventions; Emergency Situation; Enrollment; Event; Excision; Extravasation; Functional disorder; Healthcare; Hospital Costs; Hospitals; Hour; Incidence; Injury; Intensive Care Units; Intention; Intervention; Interview; Intubation; Joints; Larynx; Length of Stay; Measures; Mechanical ventilation; Medical; Meta-Analysis; Methods; Metric; Modification; Morbidity - disease rate; Nosocomial pneumonia; Operative Surgical Procedures; Pathway interactions; Patients; Performance; Phase; Phase III Clinical Trials; Pilot Projects; Pneumonia; Polyurethanes; Polyvinyl Chloride; Population; Population Heterogeneity; Positioning Attribute; Prevention; Procedures; Protocols documentation; Questionnaires; Randomized; Randomized Controlled Trials; Relative Risks; Research Personnel; Respiratory Failure; Risk; Risk Reduction; Safety; Sample Size; Suction; Surrogate Endpoint; Techniques; Telephone; Time; Trachea; Trauma; Tube; Validation; Ventilator; base; comparative effectiveness; comparative efficacy; compare effectiveness; cost; cost effectiveness; design; effectiveness trial; endotracheal; mortality; pilot trial; prevent; trial comparing

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. PUBLIC HEALTH RELEVANCE: This pilot study will provide data for planning and establish the feasibility of performing a definitive comparative effectiveness trial of two modified endotracheal tubes designed to reduce microaspiration of subglottic secretions in reducing the risk of ventilator-associated pneumonia. The study will be performed in a diverse population of critically ill patients with acute respiratory failure, and colonization of the lower airways with bacteria will be used as a surrogate for the risk of ventilator- associated pneumonia. The results from this pilot study will be used to estimate sample size and patient enrollment rates for the larger, Phase III trial.

说明（由申请人提供）：本试点研究的目的是为规划提供数据，并确定对两种专门设计的气道导管（气管插管；ETT）进行大型、随机、比较有效性试验的可行性，以预防呼吸机故障相关性肺炎（VAP）。修改位于气管中的 ETT 套囊的材料和设计，和/或通过位于管套囊和声带之间的额外端口连续抽吸声门下分泌物，可以防止套囊周围污染的分泌物泄漏，从而减少VAP 的风险。研究人员正在计划进行一项 III 期随机对照试验，比较聚氨酯套囊气管插管 (PUC-ETT) 的有效性，聚氨酯套囊气管插管还允许连续抽吸声门下分泌物 (PUC-CASS-ETT) 和传统的聚氯乙烯套囊气管插管（PVC-ETT）用于呼吸衰竭的机械通气患者。在启动 III 期试验之前，需要进行较小规模的试点研究，以确定可行性并收集终点数据，从而确定最终试验的入组率和项目样本量。出于规划目的，将从每日定量培养中评估 VAP 的替代物——气管细菌定植，以估计两种研究装置的效应大小。次要目标包括确定这些 ETT 的放置是否对其他重要临床终点（包括无呼吸机天数、28 天死亡率、重症监护室和住院时间）产生有益影响，并确定设备的安全性通过评估移除 ETT 后持续存在的上呼吸道并发症。大约 90 名在院内或院外接受紧急气管插管的危重患者将被随机分配接受三种 ETT 中的一种。 VAP 将根据支气管肺泡灌洗液培养物使用客观标准进行诊断。管子的安全性将采用多方面的方法进行评估，包括喉功能障碍的短期客观测量以及通过出院后电话访谈和设备记录对上呼吸道问题进行长期主观和客观评估。相关不良事件。 公共健康相关性：这项试点研究将为规划提供数据，并确定对两种改良气管插管进行明确的有效性比较试验的可行性，这些改良气管插管旨在减少声门下分泌物的微抽吸，从而降低呼吸机相关性肺炎的风险。该研究将在患有急性呼吸衰竭的不同危重患者群体中进行，下呼吸道细菌定植将作为呼吸机相关性肺炎风险的替代指标。这项试点研究的结果将用于估计更大规模的 III 期试验的样本量和患者入组率。