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临床试验/NCT06154811
NCT06154811招募中不适用

Predicting Extubation Outcomes in Mechanically Ventilated Patients Using PW-TDI Diaphragmatic Kinematics and Traditional Ventilation Parameters: A Prospective Study

Affiliated Hospital of Jiangnan University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Successful Removal of Endotracheal Tube

研究概览

简要总结

Determining the appropriate extubation timing for mechanically ventilated patients is a critical issue in the Intensive Care Unit (ICU). Early or delayed extubation may prolong mechanical ventilation and ICU stay, leading to an increased mortality rate. Currently, extubation timing relies solely on the Spontaneous Breathing Trial (SBT), but its reliability is relatively low, with a extubation failure rate ranging from 10% to 40%. Therefore, accurately predicting potential post-extubation issues and early identification of reasons for SBT trial failure are crucial for improving patient outcomes. Commonly used parameters for assessing readiness for extubation do not fully reflect organ dysfunction, and the investigators plan to utilize comprehensive techniques, including bedside lung and diaphragm ultrasound parameters, to enhance the accuracy of predicting extubation outcomes in patients who pass the SBT trial.

详细描述

All patients included in the study underwent a spontaneous breathing trial (SBT) using pressure support ventilation (PSV) strategy. This strategy employed pressure support(PS)≤9 cmH2O and positive end-expiratory pressure (PEEP)≤5 cmH2O. The duration of the trial was 30 minutes, and the FiO2 level was set at the same level (≤0.5) used during mechanical ventilation. After successful completion of the spontaneous breathing trial (SBT), ultrasound images were promptly acquired, and the Rapid Shallow Breathing Index (RSBI) was calculated based on the values displayed by the ventilator . Simultaneously, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score was computed and recorded. The decision to extubate, made by the attending physician (unaware of the ultrasound examination parameters), was based on clinical judgment. The primary endpoint event was extubation failure, defined as successful completion of SBT but an inability to sustain spontaneous breathing for more than 48 hours without noninvasive or invasive ventilation support.

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

入选标准

  • Patients were enrolled if participants had been intubated and mechanically ventilated for more than 24 hours and were ready for participants first SBT according to ICU weaning criteria.

排除标准

  • paralytic drugs taken within 24 hours prior to the trial;
  • diagnosis of diaphragmatic paralysis or paradoxical movement of the hemidiaphragm detected by ultrasound or poor imaging quality;
  • Pregnancy;
  • age<18years;
  • Post-thoracotomy;
  • Existence of pneumothorax;
  • presence of large pleural effusion, subcutaneous emphysema, flail chest or right-sided rib fractures;
  • presence of neuromuscular diseases.

结局指标

主要结局

Successful Removal of Endotracheal Tube

时间窗: The patient undergoes a spontaneous breathing trial, and measurements are taken 30 minutes after the removal of the endotracheal tube.

Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation.

次要结局

未报告次要终点

研究者

发起方
Affiliated Hospital of Jiangnan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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