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临床试验/NCT01393431
NCT01393431终止不适用

Exhaled Breath Condensate pH in Mechanically Ventilated Patients

Universidad Nacional de Rosario1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
1
主要终点
Exhaled Breath Condensate (EBC)pH of expiratory trap and Exhaled breath condensate pH obtained with coolant chamber and deaerated with Argon

研究概览

简要总结

Measurement of pH in Exhaled breath condensate has been mentioned as a robust variable from lung inflammation. It is non-invasive and reproducible. The investigators measured pH in the water condensed in the trap of expiratory arm of ventilator.In ICU the investigators measured pH in condensed water without interfering with patients treatment. A group of critically ill patients mechanically ventilated due to non pulmonary cause were followed until successful weaning, death or pneumonia. The investigators found that pH did not change along the study and it did not predict worsening condition.

详细描述

Collection of exhaled breath condensate (EBC) became a promising method for obtaining samples from the lungs. In this prospective clinical trial we aimed to answer if spontaneous EBC in the trap of the expiratory arm of the ventilator could replace EBC collected by coolant chamber with gas standardization with Argon as an inert gas. Second, if EBC pH could predict ventilator associated pneumonia (VAP) and mortality. We included a group of critically ill patients, that required mechanical ventilation due to non-pulmonary cause. The patients were followed up until development of VAP, successful weaning or death.EBC pH spontaneously collected in the trap of expiratory arm of the ventilator. We measured pH with a blood gas analyzer, named Radiometer ABL5 Copenhagen. For the coolant chamber EBC pH measurement, the expiratory arm was passed through the chamber at -3ºC and in 10 min at least 2 ml was collected. The rest of the EBC was collected in Ependorff tube and pH was measured after de-aeration of the condensate with argon (350 ml/min) for 10 min as a gas standardization procedure as previously described by Hunt and colleagues. [Hunt JF, Fang K, Malik R, Snyder A, Malhotra N, Platts-Mills TAE, Gaston B. Endogenous airway acidification: implications for asthma pathophysiology. Am J Resp Crit Care Med 2000; 161: 694-699. ]

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

  • Endotracheal intubation and mechanical ventilation for at least 48 hours due to non-pulmonary cause
  • For whom their close acquaintances gave the informed consent

排除标准

  • Pregnancy, denied surrogate decision-makers to give informed consent.
  • Patients that required mechanical ventilation due to: pneumonia, severe respiratory infection, massive haemoptysis, acute severe asthma, bronchiectasis, COPD exacerbation, or acute lung injury. Finally, patients that expected to be ventilated less than 2 days.

结局指标

主要结局

Exhaled Breath Condensate (EBC)pH of expiratory trap and Exhaled breath condensate pH obtained with coolant chamber and deaerated with Argon

时间窗: follow up during mechanical ventilation, averaged less than 4 weeks

It was an observational study that showed no changes in EBC pH despite different patient´s outcome. We, as investigators, did not make any intervention.

次要结局

  • Exhaled breath condensate pH could predict ventilator associated pneumonia or death(Follow up during mechanical ventilation (averaged less than 4 weeks))

研究者

申办方类型
Other

研究点 (1)

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