Risk Factors for Prolonged Invasive Mechanical Ventilation in COVID-19 Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 20
- 主要终点
- Duration of mechanical ventilation and 28 days ventilator free days
研究概览
简要总结
This multicentric prospective clinical practice study aims at evaluating clinical factors associated with a prolonged invasive mechanical ventilation and other outcomes such as mortality and ICU length of stay in patients affected from COVID-19 related pneumonia and ARDS.
详细描述
Background
On February 21th 2020, SARS-CoV-2 outbreak erupted in Italy and, in the immediately subsequent period, all the Italian regional Health Systems had to face with an overwhelming increase of COVID-19 admissions requiring isolation, oxygen, ventilation and ICU beds.
The COVID-19 related pneumonia presented as a particular entity in terms of clinical management and different ICUs adopt different clinical strategies, sometimes this is due to the local resources' availability. Mortality rate of the patients admitted to ICU is up to 26%.
To date, it is not clear which clinical, pharmacological and radiologic factors relate to a prolonged duration of mechanical ventilation, mortality and ICU length of stay and it's urgent to understand these aspects in order to develop optimal strategies to allow faster but safe paths for these patients.
Hypothesis and significance
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
- •Age ≥ 18 years
- •ICU admission because of the need of mechanical ventilation in the context of COVID-19 related pneumonia (swab proven)
排除标准
- •COVID-19 related pneumonia complicating the clinical course of patients admitted to the ICU for another reason (e.g. trauma, stroke)
结局指标
主要结局
Duration of mechanical ventilation and 28 days ventilator free days
时间窗: 28 days
Ventilator free days (VFDs) will be calculated in a time frame of 28 days, the beginning of observation will coincide with the day of intubation and observation will end after successful disconnection from mechanical ventilation. For intubated patients, post extubation non invasive ventilation (NIV) will not be accounted as a ventilation period, in case of interval reintubation within 28 days, VFDs will be counted from the last successful extubation. For tracheostomized patients, ventilator free days will be counted after successful disconnection from mechanical ventilation and interval reconnections will be considered in the ventilation interval as for intubated patients.
次要结局
- 30 days survival after ICU discharge(30 days)
- 90 days survival after ICU discharge(90 days)
- Quality of life at 1 year after ICU discharge and persistent symptoms(1 year)
- Pulmonary function tests at 1 year - FEV1/FVC%(1 year)
- ICU Mortality(60 days)
- Quality of life at 90 days after ICU discharge measured with 15D instrument(90 days)
- Radiologic aspects - structured description of CT and RX data(90 days)
- Pulmonary function tests at 1 year - FEV1%(1 year)
- Pulmonary function tests at 1 year - FVC%(1 year)
- Radiologic aspects at 1 year CT scan(1 year)
- Pulmonary function tests at 1 year -(1 year)