Practice of Ventilation in Critically Ill Patients Without Acute Respiratory Distress Syndrome - An International Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,030
- 试验地点
- 13
- 主要终点
- Tidal Volume Size
研究概览
简要总结
The purpose of this international, multicenter study is to determine ventilation practice and outcomes of intubated and ventilated intensive care unit (ICU) patients. Ventilation characteristics and outcomes will be compared between patients without the acute respiratory distress syndrome (ARDS), patients at risk for ARDS, and patients with mild, moderate or severe ARDS.
Participating centres worldwide will include adult patients undergoing mechanical ventilation in the ICU during a 7-day period. Patients data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until day 90. Primary endpoint is the tidal volume size used during mechanical ventilation. 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, extra-pulmonary complications, duration of ventilation, length of ICU and hospital stay, and ICU, hospital and 90-day mortality.
详细描述
Research questions:
- Does ventilation practice, in particular tidal volume size, varies amongst patients without ARDS, patients at risk for ARDS, and patients with mild ARDS?
- Are tidal volumes used in patients without ARDS higher than those used in patients with ARDS?
- Are the outcomes in patients without ARDS dependent on the size of tidal volumes?
- Methods: In this international observational study, consecutive patients in the ICU under mechanical ventilation are eligible for participation. Patients in participating centers will be screened on a daily basis. Patients in mechanical ventilation will be included during a 7-day period, from Monday at 8:00 AM to the next Monday at 7:59 AM (in time zones of the participating centers). The inclusion period will be flexible for participating centers and determined at a later stage together with the study-coordinator.
Times points of data collection:
- Demographic data and baseline data, including severity scores (e.g. APACHE II-scores and SAPS III) and LIPS, are collected from the clinical files on the day of intubation
- Ventilation settings, gas exchange variables and vital parameters are collected once a daily in the morning, until ventilation is stopped
- Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are obtained)
- Predefined complications are recorded from medical chart until discharge from ICU or death, whatever comes first
- Length of ICU and hospital stay, and ICU, hospital and 90-day mortality
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 a participating ICU
- •Intubated in the participating ICU, or in the emergency room or operation room before the present ICU admission
排除标准
- •Age < 18 years
- •Receiving only non-invasive ventilation
- •Patients under invasive mechanical ventilation previous to the 7-day period of inclusion
- •Patients transferred from another hospital under invasive mechanical ventilation
结局指标
主要结局
Tidal Volume Size
时间窗: During mechanical ventilation
Tidal volume size in milliliters per kilogram of predicted body weight
次要结局
- Other Ventilation Parameters(During mechanical ventilation)
- Development of ARDS(From date of inclusion until the date of first documented ARDS or date of hospital discharge or death from any cause, whichever came first, assessed up to three months)
- Worsening of ARDS(From date of inclusion until the date of first documented worsening of ARDS or date of hospital discharge or death from any cause, whichever came first, assessed up to three months)
- Other Pulmonary Complications(From date of inclusion until the date of first documented pulmonary complication or date of hospital discharge or death from any cause, whichever came first, assessed up to three months)
- Need for Tracheostomy(From date of inclusion until the date of first documented tracheostomy or date of hospital discharge or death from any cause, whichever came first, assessed up to three months)
- Extra-Pulmonary Complications(From date of inclusion until the date of first documented extra-pulmonary complication or date of hospital discharge or death from any cause, whichever came first, assessed up to three months)
- Duration of Mechanical Ventilation(During mechanical ventilation)
- Length of Stay in ICU on Day 90(Until day 90)
- Length of Stay in Hospital on Day 90(Until day 90)
- All-cause ICU Mortality(Until day 90)
- All-cause Hospital Mortality(Until day 90)
- Pulmonary Infection(From date of inclusion until the date of first documented pulmonary infection or date of hospital discharge or death from any cause, whichever came first, assessed up to three months)
研究者
Prof. Dr. Marcus J. Schultz
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)