Fourth International Study of Mechanical Ventilation From VENTILA GROUP
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- ICU Mortality,
研究概览
简要总结
A prospective, international and multicenter, non interventional single-cohort study, which will enroll consecutive adult patients who have received mechanical ventilation (invasive and noninvasive ventilation) for at least 12 hours during a 1-month period, and will follow each patient for the duration of mechanical ventilation, up to 28 days. The main objectives will be to analyze the mortality and clinical outcomes in ventilated patients and secondly, to evaluate the practices of liberation from mechanical ventilation, the failure of non invasive ventilation in the ICU, and to analyze the clinical outcomes in specific populations of critically ill patients with the need of mechanical ventilation.
详细描述
Mechanical ventilation is commonly used in patients admitted to intensive care units (ICUs). Clinical studies have investigated some of the aspects associated with its utilization, and have contributed to improve the knowledge and management of patients with acute respiratory failure. In 1998, the main researchers conducted the first international study on mechanical ventilation, including 5183 patients who were mechanically ventilated longer than 12 hours. Six years later, the investigators carried out the second international study on mechanical ventilation including 4968 patients. These studies allowed to analyze the evolution of mechanical ventilation and to judge the concordance of practice with results of randomized trials. The main finding of this study was the high degree of concordance between observed changes in mechanical ventilation practice and changes predicted from reports of randomized controlled trials. However, despite apparently beneficial changes in ventilatory practice, the results did not able to detect significant differences in clinical outcomes over this time period. These results have served as an updated benchmark on the usual care and outcomes of mechanically ventilaed patients in a 'real-world' setting. Lastly, in 2010 the main researchers finished the Third International Study of Mechanical Ventilation and were able to find out, for the first time, a significant reduction of ICU mortality in mechanically ventilated patients. Then, the investigators propose to lead up the fourth-international study of mechanical ventilation. This study will keep the same methodology and it will be a prospective, international and multicenter non interventional single-cohort study, which will enroll consecutive patients who have received mechanical ventilation (invasive and noninvasive ventilation) for at least 12 hours during a 1-month period, and will follow each patient for the duration of mechanical ventilation, up to 28 days. Despite of all the current implementations in different ventilatory strategies, and new ventilatory modalities, the mortality and clinical outcomes in critically ill patients under mechanical ventilation is poorly known all over the world. The aims of this study are:
- To evaluate the impact and clinical outcomes in ventilated patients over the world; and to determine the factors associated with the clinical outcomes in ventilated critically ill patients
- To analyze the aspects related with the process of liberation from mechanical ventilation;
- To determine the clinical outcomes of patients with failure of noninvasive ventilation (NIV) in the ICU;
- To evaluate what differences may occur between geographical areas in the ventilatory management of mechanically ventilated patients.
- To describe the clinical outcomes in specific populations of critically ill patients with the need of mechanical ventilation:
5.a: Outcomes of prolonged mechanically ventilated patients. 5.b: Prevalence of delirium in mechanically ventilated patients. 5.c: Performance of tracheostomy and outcomes of tracheostomized patients. 5.d: Outcomes of mechanically ventilated patients due to neurologic diseases. 5.f: Outcomes of mechanically ventilated patients due to chronic obstructive pulmonary disease.
5.g: Outcomes of mechanically ventilated patients due to acute renal failure. 5.h: Outcomes of mechanically ventilated patients due to hypercapnia in patients with acute respiratory distress syndrome (ARDS).
5.i: Prediction and Prevalence of ICU acquired weakness (ICUAW) in mechanically ventilated 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are admitted to the ICU and will require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours.
- •Patients who are admitted to the ICU and will require NIV (Continuos Positive Airway Pressure [CPAP], or refers to Bilevel Positive Airway Pressure [BIPAP] with oronasal, nasal, helmet or facial mask) for more than 1 hour.
- •Patients in whom mechanical ventilation was started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), and were then transferred to the ICU at the participating center.
排除标准
- •Pediatric ICU.
- •Post-Operators Anesthesia Recovery Room.
- •Patients less than 18 years old will be also excluded.
- •Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive NIV).
结局指标
主要结局
ICU Mortality,
时间窗: one month
number of patients admited in the ICU that died during their ICU stay for any cause
次要结局
- 28-day mortality(one month)
- duration of mechanical ventilation(one month)
- failure of noninvasive ventilation(one month)
- duration of period of liberation from mechanical ventilation(one month)
- extubation failure(one month)
- reintubation rate(one month)
- tracheostomy rate(one month)
- hospital mortality(one month)
- lenght of ICU stay(one month)
- lenght of hospital stay(one month)
研究者
Oscar Penuelas, MD
M.D
Hospital Universitario Getafe