Utility of Pulmonary, Diaphragmatic and Cardiac Ultrasound Assessment During Weaning from Mechanical Ventilation in the Critically Ill Patient: a Prospective Observational
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 429
- 试验地点
- 1
- 主要终点
- To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters
研究概览
简要总结
The ECO-WEANING study aims to improve the process of safely removing patients from mechanical ventilation in the Intensive Care Unit (ICU). Some patients have difficulty breathing on their own after being on a ventilator, which can lead to longer hospital stays and complications. This study will use ultrasound to assess lung, heart, and diaphragm function before removing the ventilator. Combining these ultrasound results, we hope to identify better patients at high risk of needing mechanical ventilation again. The goal is to help guide care decisions and improve recovery, reducing the need for re-intubation or other interventions.
详细描述
This study is a multicenter, prospective, observational trial to develop an ultrasound-based predictive model for extubation failure in mechanically ventilated ICU patients. Extubation failure, defined as re-intubation or death within 48 hours post-extubation, remains a significant challenge, occurring in 15-35% of cases. Prolonged mechanical ventilation is associated with increased morbidity, infection risk, and hospital costs. Traditional predictors, such as maximal inspiratory pressure (Pimax), rapid shallow breathing index (RSBI or Tobin index), and other clinical parameters, have shown limited accuracy in identifying patients who are ready for extubation.
Recent advances in bedside ultrasound have allowed for the assessment of key physiological functions, such as pulmonary aeration, diaphragmatic function, and cardiac performance, offering a more comprehensive approach to predicting extubation outcomes. In this study, ultrasound will be used to evaluate the modified Lung Ultrasound Score (LUS) for lung aeration, diaphragm excursion, and thickening fraction (TFdi) for diaphragmatic function, and left ventricular diastolic function (E/e') to assess cardiac performance.
Study Procedures The study will include approximately 15 intensive care units (ICUs) across Argentina, Chile, Peru, Ecuador, Italy, Spain, the United States, and Canada. Ethical approval has been obtained from each participating institution. Adult patients (≥18 years) on invasive mechanical ventilation (MV) for at least 48 hours and ready to initiate a spontaneous breathing trial (SBT) will be eligible. Ultrasound assessments will be performed between 20 and 30 minutes after initiating the trial.
Key ultrasound measures include:
Pulmonary Ultrasound (LUS score): Evaluation of anterior and lateral lung regions to assess loss of lung aeration during the SBT.
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
- •Adult patients (18 years or older).
- •Receiving mechanical ventilatory assistance for more than 48 hours.
- •The patient is deemed ready to undergo a Spontaneous Breathing Trial, as determined by the attending physician.
- •Ultrasound measurements are performed between 20 and 30 minutes after the initiation of the trial.
排除标准
- •Patients with known or diagnosed neuromuscular disease.
- •Limitation of therapeutic effort
- •History of severe valvulopathy, severe coronary artery disease, known left ventricular ejection fraction <35%, or known grade 3 diastolic dysfunction, or who are considered candidates for tracheostomy due to their severity.
- •History of home ventilatory support
- •Patients who do not have a good acoustic window or have any type of limitation to perform pulmonary, cardiac, or diaphragmatic ultrasound.
- •Patients who at the discretion of the treating medical team cannot be placed on a T-tube.
结局指标
主要结局
To develop a predictive model for extubation failure using lung ultrasound, echocardiography, and diaphragmatic parameters
时间窗: The primary outcome assessment period comprises the first 48 hours after extubation.
The primary objective of this study is to develop a predictive model for extubation failure by utilizing lung ultrasound, echocardiography, and diaphragmatic parameters. This model aims to improve the accuracy of identifying patients at risk of re-intubation or other complications after being taken off mechanical ventilation.
次要结局
- Examine the correlation between clinical criteria for preventive non-invasive ventilation and the ultrasound model's predictions(The evaluation period comprises the first 48 hours after extubation.)
- Describe the proportion of extubation failure within 7 days after extubation(The evaluation period includes the first 7 days after extubation.)
- To assess the predictive accuracy of the ultrasound model in patients who do not require non-invasive ventilation as a preventive measure against failure(The evaluation period comprises the first 48 hours after extubation.)
- Evaluate the predictive performance of the ultrasound model in patients with indication for preventive non-invasive ventilation(The evaluation period comprises the first 48 hours after extubation.)
研究者
Ignacio Fernández Ceballos
MD
Hospital Italiano de Buenos Aires