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临床试验/NCT01170156
NCT01170156已完成不适用

Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

Centre Hospitalier de Roanne2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Presence of blue dye in the trachea and/or the bronchi after the suctioning manoeuvre.

研究概览

简要总结

The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

详细描述

This clinical study aims to confirm these experimental data in patients under mechanical ventilation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • intubated with a Hi-Lo Evac tube since less than 48 hours
  • under continuous sedation
  • written consent signed

排除标准

  • hemodynamic instability
  • allergy of blue dye

结局指标

主要结局

Presence of blue dye in the trachea and/or the bronchi after the suctioning manoeuvre.

时间窗: 48 hours after the beginning of the mechanical ventilation

The cuff pressure will be first checked and reset at 30 cm H2O if needed. Next, blue dye will be instilled just above the cuff through the lumen ending in the subglottic area of the Hi-Lo Evac tube. Then a suctioning manoeuvre will be performed with a suction pressure of - 400 mbar through a 16 French suction catheter. Thereafter, a fiberoptic bronchoscopy will be performed, looking for the presence of blue dye in the trachea and/or the bronchi.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier de Roanne
申办方类型
Other

研究点 (2)

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