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临床试验/NCT01321398
NCT01321398已完成不适用

Transpulmonary Pressure Gradients in High Frequency Oscillation Study

University of British Columbia1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
To demonstrate the proof of concept that esophageal pressures can easily be obtained in patients undergoing HFO.

研究概览

简要总结

Patients with severe lung conditions occasionally require support with a special ventilator (breathing machine) called the High Frequency Oscillator (HFO). Effective ventilation requires that the pressure generated by the ventilator be as high as possible but not too high as this can damage the lungs. In patients on HFO, there is not a well defined way to measure this pressure. We will insert a small probe into the esophagus of patients on HFO to see if this is an accurate way to measure lung pressures for these patients. A better understanding of these pressures could lead to improved patient care.

详细描述

Trials have found that the use of lower tidal volumes (6 ml/kg) during conventional mechanical ventilation decreases morbidity and mortality. Compared to conventional ventilation, high frequency oscillation (HFO) is able to provide much smaller tidal volumes (1.1 - 2.5 ml/kg) and thus theoretically may provide additional lung protection. At this time, while trials of HFO in adults have been inconclusive, the use of HFO for the management of ALI/ARDS has become widespread

Patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) are critically ill and have a high mortality associated with their illness (approximately 50%). Currently, esophageal pressure monitors are used to optimize inflation pressures and improve oxygenation in conventional mechanical ventilation in patients with ALI/ARDS. With this in mind, the purpose of this study is twofold: (1) demonstrate that esophageal pressure monitors can easily be inserted in patients undergoing HFO and (2) report the transpulmonary pressures in these patients.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years of age or older
  • Receiving HFO
  • Informed Consent Obtained

排除标准

  • Esophageal lesions or esophageal surgery within the last 6 months
  • Morbid obesity - defined as a Body Mass Index (BMI) > 40
  • Unstable cervical spine injury or cervical spinal cord injury

结局指标

主要结局

To demonstrate the proof of concept that esophageal pressures can easily be obtained in patients undergoing HFO.

时间窗: 60 minutes

次要结局

  • To determine the transpulmonary pressure gradient in critically ill patients receiving HFO(60 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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