PRactice of VENTilation in Critically Ill Patients in Middle-Income Countries (PRoVENT-iMIC) - an International Multicenter Service Review Focusing on ICUs in Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,315
- 试验地点
- 51
- 主要终点
- Tidal volume size
研究概览
简要总结
The purpose of this international, multicenter service review is to describe and compare ventilation management in patients at risk of acute respiratory distress syndrome (ARDS) versus patients not at risk and patients with established ARDS, and to ascertain whether certain ventilator settings and ventilation parameters are associated with pulmonary complications or development of ARDS after start of ventilation in patients in intensive care units (ICUs) in Asian countries.
Participating centers will include adult patients undergoing mechanical ventilation in the ICU during a 28-day period. Patients' data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy, duration of ventilation, length of ICU stay and ICU mortality.
详细描述
Rationale: scarce information exists on management of mechanical ventilation in intensive care unit (ICU) patients in low- and middle-income countries.
Objective:The primary objective is to describe and compare ventilation management in patients at risk of ARDS versus individuals not at risk, and patients with established ARDS, and to ascertain whether certain ventilation settings are associated with a higher incidence of developing ARDS in patients in ICUs in Asia. PRoVENT-iMIC secondary objectives are to determine the epidemiological characteristics and clinical outcomes of patients at risk of ARDS in ICUs in Asia according to the ventilation practice applied.
Primary hypothesis: a large proportion of patients at risk of ARDS in ICUs in Asia do not receive so-called protective ventilation, defined as tidal volume < 8 ml/kg predicted body weight and a level of positive end-expiratory pressure of at least 5 cm H2O.
Secondary hypothesis: in ICUs in Asia a large proportion of patients is at risk of ARDS, as stratified by a Lung Injury Prediction Score of ≥4.
Study design: an international multicenter service review focusing on ICUs in selected middle-income Asian countries.
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
- •Admitted to an ICU participating in this study
- •Intubated in the ICU, or in the emergency room, general ward, or operation room before the present ICU admission
排除标准
- •Age < 18 years
- •Patients under invasive mechanical ventilation previous to the 28-day period of inclusion
- •Patients transferred from another hospital under invasive mechanical ventilation
- •Receiving only non-invasive ventilation (i.e., patient never received invasive ventilation during the present admission)
结局指标
主要结局
Tidal volume size
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Tidal volume size in milliliters per kilogram of predicted body weight
Positive end-expiratory pressure
时间窗: Day 1 to Day 3 from initiation of mechanical ventilation
Pressure in cm of water
次要结局
- Inspired Oxygen Concentration(Day 1 to Day 3 from initiation of mechanical ventilation)
- Peak pressure(Day 1 to Day 3 from initiation of mechanical ventilation)
- Driving pressure(Day 1 to Day 3 from initiation of mechanical ventilation)
- Patients at risk of ARDS(On the date of inclusion)
- Length of stay in ICU(Until day 35 from study initiation)
- Plateau pressure(Day 1 to Day 3 from initiation of mechanical ventilation)
- Development of ARDS(From date of inclusion until the date of first documented development of ARDS or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days)
- Respiratory Rate(Day 1 to Day 3 from initiation of mechanical ventilation)
- Pulmonary infection(From date of inclusion until the date of first documented pulmonary complication or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days)
- Minute Volume(Day 1 to Day 3 from initiation of mechanical ventilation)
- Other Pulmonary complications(From date of inclusion until the date of first documented pulmonary complication or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days)
- Worsening of ARDS(From date of inclusion until the date of first documented worsening of ARDS or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days)
- Need for tracheostomy(From date of inclusion until the date of first documented tracheostomy procedure or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days)
- All-cause ICU mortality(Until day 35 from study initiation)
- Duration of mechanical ventilation(Until day 35 from study initiation)
研究者
Prof. Dr. Marcus J. Schultz
Prof.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)