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临床试验/NCT05761613
NCT05761613进行中(未招募)不适用

Ceragenin Coated Endotracheal Tubes for the Eradication of Ventilator Associated Pneumonia - A Prospective, Longitudinal, Cross-over, Interrupted Time, Implementation Study (CEASE VAP Study)

Dr. John Muscedere2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
400
试验地点
2
主要终点
Occurrence of Ventilator Associated Pneumonia

研究概览

简要总结

Critically ill patients are at high risk of acquiring pneumonia during the time that they are mechanically ventilated. This is known as ventilator-associated pneumonia (VAP). VAP results in increased duration of mechanical ventilation, increased ICU and hospital stay, increased risk of death and increased health care costs. VAP occurs in 20% of patients and it is estimated that each case of VAP costs the health care system $10 to 15,000 Canadian. Because of its impact on patient outcomes and the health care system, VAP is regarded as an important patient safety issue and there is an urgent need for better prevention strategies.

Invasive mechanical ventilation requires the passage of an endotracheal tube (ETT) through the pharynx which is frequently colonized with bacterial pathogens and a bio-film rapidly forms on the ETT. VAP results either from aspiration of contaminated oropharyngeal secretions or from aspiration of bacteria from the bio-film. In this project, the efficacy of a novel ETT coated with an antibiotic compound that has been shown to reduce the formation of bio-film and pathogen colonization will be tested. Preliminary evidence as to whether utilization of this novel ETT reduces the occurrence of VAP and improves patient outcomes will be obtained through the conduct of a pragmatic, prospective, longitudinal, interrupted time, cross-over implementation study.

详细描述

The innovation that is being studied is a novel antibiotic coated endotracheal tube (ETT) for the prevention of ventilator associated pneumonia (VAP) in critically ill, mechanically ventilated patients. The novel ETT is the CeraShield ETT consisting of a standard ETT with an antimicrobial hydrophilic coating containing ceragenins (CSAs) on the inner and outer lumen of the device, as well as the inflatable cuff. The CSA coating on the CeraShield protects it from microbial colonization and bio-film growth. The CSA ETT is otherwise equivalent to standard ETT tubes currently in use and is licensed in Canada for clinical use as a Class 2 device.

  1. It is hypothesized that CSA coated ETTs will reduce the incidence of Ventilator Associated Pneumonia and improve clinical outcomes including antibiotic utilization when compared to ETTs currently in use.
  2. It is hypothesized that a definitive cluster randomized multi-center study is feasible and supported by the data from this study.

To test the hypotheses, an Interrupted Time Series Cross-Over Implementation Study will be used to provide preliminary evidence of the efficacy of the CeraShield ETT compared to the ETT currently used at the study center in critically ill mechanically ventilated patients. This study will inform and be modified to conduct a future large multi-center cluster randomized study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

All pneumonia outcomes will be adjudicated by a panel blinded to allocation

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult critically ill patients with respiratory failure requiring intubation

排除标准

  • Admission to hospital or ICU with a non-study ETT already in place
  • Presence of a tracheostomy on ICU admission
  • Unable to be intubated with non-study ETT
  • Declined participation in research or data collection

结局指标

主要结局

Occurrence of Ventilator Associated Pneumonia

时间窗: Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days

The primary outcome will be the occurrence of VAP defined as new, progressive, or persistent radiographic infiltrate on chest radiograph plus any 2 of the following: (1) fever (core temperature \>38°C) or hypothermia (temperature \<36°C); (2) white blood cell count less than 3.0 × 106/L or exceeding 10 × 106/L, and (3) purulent sputum

次要结局

  • Hospital Mortality(90 days)
  • Feasibility of multi-center cluster randomized trial - 1(During the trial up to 1 year from study start)
  • Airway outcomes(Within 48 hours of extubation)
  • Feasibility of multi-center cluster randomized trial - 2(During the trial up to 1 year from study start)
  • Health care utilization(28 days)
  • Antibiotic Utilization(28 days after intubation)
  • Re-intubation(Within 48 hours of extubation)
  • Acceptability of the Intervention(During the conduct of the trial up to 1 year from study initiation)

研究者

发起方
Dr. John Muscedere
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. John Muscedere

Professor of Medicine

Queen's University

研究点 (2)

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