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临床试验/NCT07109206
NCT07109206尚未招募不适用

Cardio-circulatory and Respiratory Monitoring for Prediction of Outcome in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
104
试验地点
1
主要终点
Evaluate the accuracy of non-invasive hemodynamic parameters using Electric Cardiometry to predict weaning outcome in mechanically ventilated COPD patients.

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) remains a leading cause of morbidity and mortality worldwide, often necessitating invasive mechanical ventilation (MV) during acute exacerbations. Weaning these patients from MV is a critical juncture in their care, as prolonged ventilation is associated with increased complications, including ventilator-associated pneumonia, diaphragmatic dysfunction, and higher healthcare costs. Traditional weaning indices, such as the Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP), and the Integrative Weaning Index (IWI), New Integrative Weaning Index (NIWI) have been employed to predict weaning outcomes. However, their predictive accuracy in COPD patients is variable, often due to the heterogeneous nature of the disease and the presence of comorbidities. Recent advancements have introduced non-invasive hemodynamic monitoring tools, such as the ICON® (Electrical Cardiometry), which measures parameters like cardiac output, stroke volume, and thoracic fluid content. These parameters may offer additional insights into a patient's readiness for weaning by providing real-time data on cardiovascular and fluid status, which are crucial in the weaning process. There is a scarcity of data comparing the predictive value of ICON parameters with traditional weaning indices in COPD patients. Understanding whether ICON-derived metrics can enhance weaning predictions and lead to more individualized and effective weaning strategies, reducing the duration of MV and improving patient outcomes.

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
否

入选标准

  • •All COPD patients who are mechanically ventilated for more than 48 h due to acute exacerbation and fulfilling weaning criteria will be included in the study.

排除标准

  • •Patients younger than 18 years old.
  • •Patients with pneumothorax, pleural, or pericardial effusion.
  • •Patients with injuries, burns, or wounds which precludes the proper application of the device electrodes.

结局指标

主要结局

Evaluate the accuracy of non-invasive hemodynamic parameters using Electric Cardiometry to predict weaning outcome in mechanically ventilated COPD patients.

时间窗: 2 Years

Assess the accuracy of the non-invasive hemodynamic parameters (Cardiac index, Thoracic fluid content, contractility, contractility index, systemic vascular resistance) using Electric Cardiometry device ICON® to predict the outcome of the weaning trial in mechanically ventilated COPD patients.

次要结局

  • Evaluate respiratory indices (RSBI, IWI, MIWI) as predictors of weaning outcome in mechanically ventilated COPD patients(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karim Osama Mohammed Sleem

Dr

Assiut University

研究点 (1)

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