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临床试验/NCT01765530
NCT01765530已完成不适用

Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs

研究概览

简要总结

The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear) for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume measured at extubation compared to the current standard of care. The device may therefore be clinically useful by better maintaining the ETT original function.

详细描述

After a few days of mechanical ventilation (MV), the lumen of the endotracheal tube (ETT) is coated with a thick bacterial biofilm, which is a potential source for bacterial colonization of the lower respiratory tract and ventilator-associated pneumonia (VAP). Accumulation of mucus/secretions on the interior of the ETT also effectively lowers the cross section of the ETT and increases significantly the work of breathing in intubated patients, who then require increased MV support, with prolonged intubation and ICU stay.

A primary goal for all ICUs is to shorten the time of MV, to decrease the incidence of ETT microbial colonization and ultimately VAP incidence. To meet this goal several airways technologies to maintain the ETT free from debris/bacteria have been developed in order to improve the current ventilator-liberation standards in intubated critically ill patients.

Based on preliminary laboratory, animal and clinical data, The investigators now wish to test the hypothesis that a novel commercially available ETT cleaning device can be effective in targeting two specific issues:

  • Specific aim 1: To evaluate the mean difference in ETT luminal volume of ETTs cleaned with the novel cleaning device (EndOclear) vs. ETT cleaned in the standard manner.
  • Specific aim 2: To determine whether ETTs cleaned with the novel device show a lower degree of microbial colonization for the entire period of mechanical ventilation.

Data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic resistance analysis, users' feedbacks and safety of the device will also be collected.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patients expected to be intubated for at least 48 hours or longer
  • Enrollment within 24 hours from intubation time

排除标准

  • Current and past participation in another intervention trial conflicting with the present study
  • Pregnant women and prisoners

研究组 & 干预措施

ETT cleaning manuver

Experimental

Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.

干预措施: ETT cleaning maneuver (Device)

Standard of care

No Intervention

In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.

结局指标

主要结局

Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs

时间窗: At extubation (An expected average of 5 days)

The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion.

次要结局

  • ETT Microbiology(At extubation (An expected average of 5 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert M. Kacmarek

Director, Respiratory Care Services; Professor of Anesthesia

Massachusetts General Hospital

研究点 (2)

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