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临床试验/NCT05026463
NCT05026463Unknown不适用

Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

Capital Medical University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Inspiratory effort

研究概览

简要总结

Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV

排除标准

  • History of neuromuscular disease
  • History of diaphragm dysfunction and surgery
  • History of esophageal, gastric or lung surgery
  • Decreased level of consciousness
  • Central respiratory drive dysfunction
  • Considered withholding of life support

结局指标

主要结局

Inspiratory effort

时间窗: 30 minutes

Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.

Work of breathing

时间窗: 30 minutes

Work of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.

次要结局

  • Partial pressure of carbon dioxide in arterial blood (mmHg)(30 minutes)
  • Tidal volume (ml)(30 minutes)
  • Respiratory rate (breaths/min)(30 minutes)
  • Respiratory system compliance (ml/cmH2O)(30 minutes)
  • Rapid shallow breathing index(30 minutes)
  • The use of accessory respiratory muscle(30 minutes)
  • Partial pressure of oxygen in arterial blood (mmHg)(Partial pressure of oxygen in arterial blood)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Xin Zhou

Professor

Capital Medical University

研究点 (2)

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