Drainage of Subglottic Secretions and Prevention of Ventilator-associated Pneumonia in Intensive carE Units: Medico-Economic Study With a Randomized clusTer and crossovER Design: DEMETER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,577
- 试验地点
- 49
- 主要终点
- Incremental cost-utility ratio
研究概览
简要总结
In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Age over 18 years
- •Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
- •Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
- •Information delivered
排除标准
- •Previous inclusion in the study
- •Patients moribund at the ICU admission
- •Pregnant, parturient or breast-feeding woman
- •Patient hospitalized without consent and/or deprived of liberty by court's decision
- •Patient under guardianship or curators
- •Lack of social insurance
- •Concomitant inclusion in a trial on VAP prevention
- •Patient with no comprehension of the French language
研究组 & 干预措施
Period with endotracheal tubes not allowing SSD
During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage
干预措施: Endotracheal tubes not allowing SSD (Device)
Period with endotracheal tubes allowing SSD
During this period, patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage
干预措施: Endotracheal tubes allowing SSD (Device)
结局指标
主要结局
Incremental cost-utility ratio
时间窗: 1 year after ICU admission
Incremental cost to gain an extra quality-adjusted life-year (QALY) with the SSD implementation
次要结局
- Ventilator-free days(90 days after the start of invasive mechanical ventilation)
- Budget impact analysis(5 years)
- Microbiologically-confirmed VAP density of incidence(90 days after the start of invasive mechanical ventilation)
- Microbiologically-confirmed VAP incidence(90 days after the start of invasive mechanical ventilation)
- Defined Daily Dose of antibiotics consumption(Until discharge from ICU, an expected average of 12 days)
- Duration of invasive mechanical ventilation(Until weaning of mechanical ventilation, an expected average of 10 days)
- Hospital length of stay(Until discharge from hospital, an expected average of 20 days)
- Post-extubation laryngo-tracheal dyspnea incidence(Until weaning of mechanical ventilation,, an expected average of 10 days)
- Infection related Ventilator-associated Conditions incidence(90 days after the start of invasive mechanical ventilation)
- Incremental cost-utility ratio (subgroup analysis)(1 year after ICU admission)
- Ventilator-associated Conditions density of incidence(90 days after the start of invasive mechanical ventilation)
- ICU length of stay(Until discharge from ICU, an expected average of 12 days)
- 90-days mortality(90 days after ICU admission)
- Ventilator-associated Conditions incidence(90 days after the start of invasive mechanical ventilation)
- ICU mortality(Until discharge from ICU, an expected average of 12 days)
- 180-days mortality(180 days after ICU admission)
- 1 year mortality(1 year after ICU admission)
- Incremental cost-effectiveness ratio(1 year after ICU admission)