Local Assessment of Management of Burn Patients (LAMiNAR) - a Prospective Observational International Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Ventilation parameters
研究概览
简要总结
In the general intensive care unit (ICU) population, there is strong evidence for benefit from lung-protective mechanical ventilation, including the use of low tidal volumes and adequate levels of positive end-expiratory pressure (PEEP). In burn patients it is highly uncertain whether these settings are beneficial and there are even concerns over safety of, in particular use of low tidal volumes. There is lack of international guidelines and consequently ventilation practice in burn patients may widely vary.
The primary objective is to determine ventilation practice in burn ICUs worldwide, focusing on the size of tidal volumes and the levels of PEEP used for burn patients. In addition, data on other strategies considered important in patients who receive ventilation are also collected, including data on neuromuscular blocking agents, sedatives and analgesics, and type and amount of intravenous fluids used in the period of ventilation. The secondary objective is to determine the association between tidal volume size and levels of PEEP, and duration of ventilation in burn patients.
详细描述
Patient population: Consecutive burn patients admitted to participating burn ICUs who receive invasive ventilation, irrespective of severity of burn injury and/or presence of inhalation trauma are eligible for participation.
Data collection: includes burn patients admitted within a period of three months. Demographic and baseline data are collected from the clinical files on the day of admission. If available, standard of care and clinical outcome parameters are collected daily until day 14, death or discharge from ICU, whatever comes first.
Sample size: The primary objective is to determine (variations in) ventilation practice in burn patients in burn ICUs. Therefore, the sample size is based on the main secondary objective, which is to determine the association between the following ventilator settings: tidal volume, PEEP, FiO2 and mode; and outcome of burn patients. The investigators calculated the sample size for a multiple regression model: a sample size of at least 300 patients is required to have a power of 0.80, a significance level of 0.05, using an estimated effect size of 0.04, while using 4 independent variables in the model.
Ethics Approval: National coordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centres will not be permitted to record data unless ethics approval or an equivalent waiver is in place. The investigators expect that in most, if not every participating country, a patient informed consent is not be required.
Monitoring: Due to the observational nature of the study, a DSMB is not necessary.
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
- •Admission to a participating burn ICU Need for invasive ventilation
- •Informed consent (only if applicable in the country where data are collected)
排除标准
- 未提供
结局指标
主要结局
Ventilation parameters
时间窗: Up to 14 days during mechanical ventilation
Mode of ventilation; assist-control or spontaneous modes of ventilation
次要结局
- Number of ventilator-free days and alive at day 28(From day 1 to day 28)
- All-cause ICU Mortality(Until day 90)
- Other Ventilation Parameters(Up to 14 days during mechanical ventilation)
- Length of Stay in ICU on Day 90(Until day 90)
- Need for Tracheostomy(daily up to 14 days from inclusion)
- Length of Stay in Hospital on Day 90(Until day 90)
- Daily Lung Injury Scores(Up to 14 days during mechanical ventilation)
- Complications(Daily up to 14 days from inclusion)
- All-cause Hospital Mortality(Until day 90)
- Daily Sequential Organ Failure Assessment (SOFA)-scores(Daily up to 14 days from inclusion)
研究者
Prof. Dr. Marcus J. Schultz
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)