PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,122
- 试验地点
- 22
- 主要终点
- Positive end-expiratory pressure
研究概览
简要总结
The purpose of this national, multicenter service review is to determine and compare ventilation management in COVID-19 patients in the Netherlands, and to determine whether certain ventilation settings have an independent association with duration of ventilation.
In every adult invasively ventilated COVID-19 patient from a participating ICU, granular ventilator settings and parameters will be collected from start of invasive ventilation for up to 72 hours. Follow up is until ICU and hospital discharge, and until day 90. The primary outcome includes main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate). Secondary endpoints are ventilator-free days and alive at day 28 (VFD-28); duration of mechanical ventilation; use of prone positioning and recruitment maneuvers; duration of ICU and hospital stay; incidence of kidney injury; and ICU, hospital, 28-day and 90-day mortality.
详细描述
Rationale:
The novel coronavirus disease (COVID-19) pandemic is rapidly expanding across the world, with over 60.000 new cases each day as of late March 2020. Healthcare workers are struggling to provide the best care for patients with proven or suspected COVID-19. Approaches for clinical care vary widely between and within countries and new insights are acquired rapidly. This includes the way invasive ventilation is applied.
Objective:
To determine and compare invasive ventilation settings and parameters in COVID-19 patients in the Netherlands, and to determine associations with clinical outcomes.
Hypotheses:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •COVID-19, confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT)
- •Suspected COVID-19 infection, with no exclusion of diagnosis
- •Having received invasive ventilation
排除标准
- •Age <18 years
- •Already included in the same study in another hospital
- •Having had received invasive ventilation > 24 hours in a non-participating hospital
结局指标
主要结局
Positive end-expiratory pressure
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Level of pressure support above positive end-expiratory pressure (PEEP)
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Inspired fraction of oxygen
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Ventilation Mode
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Set and measured respiratory rate
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Tidal volume set
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Expiratory tidal volume
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Inspiration to expiration ratio
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
次要结局
- Use of recruitment maneuvers(Day 1 to Day 3 from initiation of mechanical ventilation)
- Incidence of acute kidney injury(Until 28 days from initiation of mechanical ventilation)
- Duration of hospital stay(Until 28 days from initiation of mechanical ventilation)
- ICU mortality(Until 28 days from initiation of mechanical ventilation)
- Duration of ventilation in survivors;(Until 28 days from initiation of mechanical ventilation)
- Use of prone positioning(Day 1 to Day 3 from initiation of mechanical ventilation)
- Hospital mortality(Until 28 days from initiation of mechanical ventilation)
- 28-day mortality(Until 28 days from initiation of mechanical ventilation)
- Number of ventilation-free days and alive at day 28(Until 28 days from initiation of mechanical ventilation)
- 90-day mortality(Until 90 days from initiation of mechanical ventilation)
- Duration of ICU stay(Until 28 days from initiation of mechanical ventilation)
研究者
Prof. Dr. Marcus J. Schultz
Prof.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)