跳至主要内容
临床试验/NCT03842280
NCT03842280Unknown不适用

Assessments of Diaphragm-pleural Mechanics During the Weaning From Prolonged Mechanical Ventilation

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Weaning success

研究概览

简要总结

Weaning failure from mechanical ventilator is commonly seen in respiratory failure and increases duration of ventilator use, ICU stay, ventilator associated pneumonia and even mortality. The diaphragm serves as one of the most important respiratory mechanism and its function differs the weaning success rate. Since 1980s, ultrasonography assessment in diaphragm movement were developed and further discussion upon whether it serves as a predicting factor for extubation failure. The measurement includes difference of diaphragm thickness, diaphragm excursion or the movement of liver and spleen.

Multiple studies targeted intubated patients with different measurement methods and all resulted with good weaning prediction value.6 Of all the studies, only one study targeted tracheostomy tube patients. They reported diaphragm thickness fraction >36% as cutoff value is associated with successful spontaneous breathing trial (SBT), with a sensitivity of 0.82, specificity of 0.88. However, little comparison with traditional weaning parameters was mentioned in the study. We designed this prospective observational study to evaluate whether diaphragm movement under ultrasound serves as a predicting index of ventilator discontinuation in patients with tracheostomy. The diaphragm movement will also correlate with other parameters such as RSBI, Pi max, Pe max, Tv spont., WEANSNOW score(WS), VO2, APACHE II. Esophageal pressure is also provided as an option for our study population for more information such as pleural pressure, transdiaphragm pressure, etc.

The ultrasonography measurement of diaphragm movement will be performed within 6 hours before discontinuation of ventilator. The patient remains in semi-recumbent position with the convex probe selected for its good penetration. The probe is placed at a craniocaudal axis, 90 degrees to the skin at the lower intercostal spaces to right anterior axillary line (AAL) and left posterior axillary line (PAL), which allows a perpendicular ultrasound beam direction to the diaphragm movement. Liver (border or vascular structure), splenic (border or vascular structure) will be selected as target point and the marked distance of movement during quiet respiration cycle will be measured 10 times with a largest value calculated. Other echo measurements will also be attempted.

The study aims to investigate if the measurement of the diaphragm movement serves as a reliable predicting factor for weaning failure in respiratory care center 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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prolonged mechanical ventilation with tracheostomy tube
  • Oxygen with a fraction of ≤ 0.4
  • Positive end expiratory pressure at ≤ 5 cm H2O
  • Pressure support at ≤ 8 cmH2O

排除标准

  • No spontaneous breathing
  • Unstable hemodynamic status,
  • History of peritonitis, intraabdominal operation, empyema, or pleurodesis.

结局指标

主要结局

Weaning success

时间窗: 1 month

Liberation from mechanical ventilation

次要结局

  • Ventilator free 30 days after liberation(30 days after liberation)
  • Ventilator free 60 days after liberation(60 days after liberation)
  • Ventilator free 90 days after liberation(90 days after liberation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验