Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effects of ventilatory mode on calibrated esophageal ballon best volume
研究概览
简要总结
Esophageal balloon calibration (EBC) has been proposed during controlled mechanical ventilation in intubated patients in order to optimize esophageal pressure (Pes) signal. Actually, at our knowledge, no data exist about EBC during assisted ventilatory modes such as Pressure Support Ventilation (PSV). The primary endpoint of the present investigation is to assess the feasibility of EBC during PSV and PSV plus Sigh.
详细描述
Assisted ventilatory modes, nowadays, have been proved to reduce complications related to controlled mechanical ventilation. With these modes, ventilatory cycling is under the patient's control to an extent depending on the type of ventilatory modality.
Sigh improves oxygenation and lung mechanics during pressure control ventilation and pressure support ventilation (PSV) in patients with acute respiratory distress syndrome.
In order to better quantify the effects of both PSV and PSV plus Sigh on respiratory mechanics, the esophageal pressure monitoring could be helpful. However, esophageal pressure (Pes) assessment requires esophageal ballon calibration (EBC) as demonstrated in intubated patients under controlled mechanical ventilation.
At our knowledge, no data exist about EBC during assisted ventilatory modes. The primary aim of the present study is to evaluate the effects of PSV and PSV plus Sigh ventilation on esophageal balloon best volume in patients admitted to the intensive care unit for acute respiratory failure.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •patients older than 18 years;
- •undergoing mechanical ventilation for more than 24 hours (in volume-controlled mode) and with readiness to run assisted ventilation;
排除标准
- •severe COPD with air trapping clinical suspicion;
- •hemodynamic instability requiring inotropic or vasopressor support;
- •any contraindications to esophageal catheter positioning
研究组 & 干预措施
EBC-assisted
A nasogastric tube, equipped with esophageal and gastric balloons, will be inserted in each patient enrolled in the study. After definitive catheter positioning has been obtained, Esophageal ballon calibration will be run in volume-controlled ventilation, pressure support ventilation and sigh + pressure support ventilation.
干预措施: EBC-assisted (Other)
结局指标
主要结局
Effects of ventilatory mode on calibrated esophageal ballon best volume
时间窗: Over 120 minutes in PSV
Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes
Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh
时间窗: Over 30 minutes in PSV + Sigh
Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh
次要结局
- Changes of respiratory mechanics indices in PSV + sigh(over 30 minutes in PSV + Sigh)
- Gas exchange(over 30 minutes during each trial)
- Changes of respiratory mechanics indices in PSV(over 30 minutes in PSV)
研究者
Gianmaria Cammarota
Physician in staff of the ICU
Azienda Ospedaliero Universitaria Maggiore della Carita