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临床试验/NCT03946371
NCT03946371Unknown不适用

Relation Between the Volume of Subglottic Secretion and Risk of Extubation Failure in ICU Patients

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年4月26日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Extubation failure

研究概览

简要总结

This study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the ICU patient.

详细描述

Between 10 and 20% of patients develop extubation failure (10.7% in our ICU at 2018), which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. Tracheal secretions, LVEF<30%, MV > 7d, Weak of cough are identified as risk factors of extubation failures but are not completely performants. Avoiding reintubation remains an important clinical goal.

The subglottic secretion drainage above the cuff of an endotracheal tube is recognized as an effective method to prevent ventilator-associated pneumonia (VAP) in critically ill patients. The subglottic secretion drainage is used in a regular way in our ICU. Volume of subglottic secretion is not analysed in the scientific literature.

Study :

The investigators hypothesize that high volume of subglottic secretion before extubation is associated with high risk of extubation failure and à high risk of pneumonia post extubation.

All planned extubations in the intensive care unit after 2 days minimal of mechanic ventilation are recorded on a designated form and standard variables charted. All data will be collected retrospectively after the extubation event.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 an orotracheal tube with a subglottic aspiration for more than 24 hours
  • mechanical ventilation for more than 48 hours
  • planned extubations in the intensive care

排除标准

  • age < 18 years
  • terminal extubation
  • Self extubation
  • Pregnancy

结局指标

主要结局

Extubation failure

时间窗: 48 hours

defined as a need for reintubation within 48 h after extubation

Volume of Subglottic Secretion

时间窗: 24 weeks

Quantity (ml) of pre-extubation subglottic secretion during the duration of mechanical

次要结局

  • Pneumonia post extubation(7 days)
  • Length of stay in ICU(22 month)
  • Weaning mechanical ventilation failure(7 days)
  • Mortality(28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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