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临床试验/NCT06494215
NCT06494215招募中不适用

Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Patients Undergoing Invasive Mechanical Ventilation Under Pressure Support Mode

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
3. Magnitude of respiratory effort

研究概览

简要总结

The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.

详细描述

Respiratory mechanics and regional ventilation will be monitored by electrical impedance tomography (Enlight 1800 and 2100, Timpel). Esophageal and gastric pressures will be obtained by placing an esophageal/gastric balloon cathether (Nutrivent ®), validation concerning position will be done through modified Baydur maneuver (delta esophageal/delta airway pressure = 0.8-1.2). The hardware Pneumodrive will be used to inflate the balloon and store the airway, gastric and esophageal pressures.

Initially the patients will be monitored with EIT for aproximately 30 minutes after pletismography stabilization. Then, an arterial blood-gas sample shall be collected for analysis. Next, three expiratory and three inspiratory pauses of at least two seconds will be realized with intervals of eight respiratory cycles between them, allowing plateau pressure to be recorded and global and regional driving pressure to be estimated. All this data will be stored for later analysis. The same procedures and measurements shall be made sequentially with a 50% higher pressure support and with a 50% lower pressure support.

研究设计

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

盲法说明

None (Open Label)

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

  • Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)

排除标准

  • Age less than 18 years; sedation or neuromuscular blockade; absence of respiratory effort; contraindications to esophageal balloon cathether positioning or electrical impedance tomography belt positioning; presence of pneumothorax or active air leaks; hemodynamic instability; absence of informed consent.

结局指标

主要结局

3. Magnitude of respiratory effort

时间窗: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS

Respiratory effort shall be estimated through expiratory pauses and though recording of esophageal pressure at different pressure support levels. These data shall be compared to Pendelluft magnitude according to the different methods of calculation

1. Magnitude of Pendelluft

时间窗: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS

Three differents methods of estimating magnitude of Pendelluft shall be compared using a software based on electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil)

2. Magnitude of Pendelluft during inspiratory pause

时间窗: During 30 minutes after plethysmogram stabilization at clinical PS, during 30 minutes at 50% lower PS, and during 30 minutes at 50% higher PS

One of the methods of Pendelluft measurement shall be performed during an inspiratory pause for comparison with a normal cycle (without pause).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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