Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation Mode in Patients With Acute Respiratory Failure in ICUs in Latin America
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 422
- 试验地点
- 10
- 主要终点
- Ventilator- free days
研究概览
简要总结
The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America and its association with patient outcomes.
The main questions it aims to answer are:
- what is the prevalence of the use of low tidal volume ventilation (VT <8 mL/kg of predicted body weight) in the first 24 hours of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure?
- Is there an association between the rate of adherence to low tidal volume ventilation in spontaneous ventilation modes and the ability to stay off ventilatory support and mortality?
Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants
- 24 hours before they begin to be ventilated with spontaneous modes of ventilation
- during the first 24 hours of spontaneous ventilation
Investigators will collect several patient-centered clinical outcomes at 28 days after study inclusion, including ventilator-free days and mortality
详细描述
Investigators will conduct a cohort study in Intensive Care Units (ICUs) across Latin America, aiming to include 422 patients with Hypoxemic Acute Respiratory Failure (ARF) and under invasive mechanical ventilation.
The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America
The primary objectives are to determine the prevalence of low tidal volume ventilation (VT < 8 mL/kg of predicted body weight) during the initial 24 hours of spontaneous ventilatory modes in patients diagnosed with hypoxemic ARF and its association with clinically important patient outcomes. Investigators are interested in assessing the rate of adherence to low tidal volume ventilation, defined as maintaining VT < 8 mL/kg of predicted body weight during the first 24 hours of ventilation in spontaneous mode.They are also interested in measuring the number of days that patients are alive and not receiving ventilatory support and survival at 28 days.
Investigators will also measure the proportion of patients experiencing significant asynchrony during the transition to spontaneous mechanical ventilation, who revert to sedation and controlled mechanical ventilation within the first 24 hours or at any point during mechanical ventilation.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio <300 mmHg, under controlled invasive mechanical ventilation, with an expected duration of MV of at least 24h.
- •Patients transitioning to spontaneous ventilation modes (PSV, PAV Plus, NAVA or APRV)
排除标准
- •Tracheostomized patients.
- •Decision not to maintain or add life support measures on the day of assessment (palliative care).
- •Patient in ECMO.
- •Air fistula or barotrauma that prevents adequate tidal volume monitoring.
- •Severe injuries to the central nervous system that result in abolished or very high respiratory drive, for whom it is not possible to maintain protective tidal volume.
结局指标
主要结局
Ventilator- free days
时间窗: 28 days
number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
Low tidal volume
时间窗: 24 hours
Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
次要结局
- Hospital mortality(28 days)
- Rate of patient-ventilator asynchrony(24 hours)
- Number of participants that return to controlled mechanical ventilation in the first 24 hours(24 hours)
- Number of participants with PEEP and FIO2 compatible with the ARDSnet PEEP/FIO2 table(24 hours)
- Number of participants who were extubated(28 days)
- Number of participants that return to controlled mechanical ventilation after transition to spontaneous ventilation(28 days)
- Number of participants that return to sedation in the first 24 hours(24 hours)
- Number of participants that return to sedation after transition to spontaneous ventilation(28 days)
- Rate of reintubation(28 days)