Impact of the Addition of a Device Providing Continuous Pneumatic Regulation of Tube Cuff Pressure to an Overall Strategy Aimed at Preventing Ventilator-associated Pneumonia in the Severe Trauma Patient. A Multicentre, Randomised, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 26
- 主要终点
- Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition
研究概览
简要总结
Ventilation-associated pneumonia is the main site of healthcare-associated infections in the severe trauma patient, with a mean incidence rate of 35%. Ventilator-associated pneumonia increases morbi-mortality, length of stay in intensive care and overall management costs. As was recalled by the jury of the 2008 SFAR-SRLF consensus conference on the prevention of nosocomial infections contracted in intensive care, success in this preventive endeavour depends on a number of measures: orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm H2O, maintaining a semi-seated position ≥30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation.
Devices ensuring continuous pneumatic control of tube cuff pressure are more efficient in maintaining tracheal balloon pressure than intermittent adjustments using a hand-held manometer. In one study, these devices clearly facilitated diminution of microaspiration of gastric contents and of ventilator-associated pneumonia incidence density (9.7 vs. 22 VAP/1000 days of mechanical ventilation; p = 0.005).
The investigators are putting forward the hypothesis that by adjoining a device providing continuous pneumatic regulation of tube cuff pressure to an overall strategy aimed at ventilator-associated pneumonia prevention (including semi-recumbent position ≥30°, oro-nasal-pharyngeal care at regular intervals and reduced risk exposure) can decrease VAP incidence by 50% in severely traumatised patients whose condition necessitates mechanical ventilation of an expected duration exceeding 48h.
Ours is the first large-scale study to evaluate the interest of an innovative technology bundle on decrease of ventilator-associated pneumonia incidence in one of the intensive care populations the most at risk, namely severe trauma patients, a population presently benefiting from the other recommended preventive measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
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
- •Patients having a severe trauma as defined by an Injury Severity Score (ISS) >15,
- •Aged at least 18 years,
- •Intubated for less than 15h,
- •Necessitating recourse to mechanical ventilation for an expected period ≥ 48h,
- •Participating in a social security scheme or benefiting from such a scheme by means of a third party.
排除标准
- •Patient likely to die over the 48h following admission,
- •Nasotracheal intubation,
- •Patient intubated through a tracheal tube with subglottic secretion drainage
- •Intubation carried out 24h or more after the trauma,
- •Ventilation with tracheotomy,
- •Refusal to participate in the research,
- •Contraindication to the head-up position,
- •Participation in another research protocol focusing on an anti-infective treatment or on a measure decreasing the risk of infection,
- •Persons benefiting from reinforced protection or persons deprived of freedom subsequent to a legal or administrative decision, minors under legal protection
结局指标
主要结局
Proportion of patients having developed VAP at D28 in intensive care according to the ATS definition
时间窗: 28 days
次要结局
- Time to first episode of VAP diagnosis according to the ATS definition(max 60 days)
- Number of ventilator free days(max 60 days)
- Proportion of patients having developed VAP in ICU according to the ATS definition(max 60 days)
- Number of antibiotic free days(max 60 days)
- Proportion of patient who died during their ICU stay(max 60 days)
- Proportion of patients requiring corticosteroids or bronchodilators within 48 hours of tracheal extubation(max 60 days)
- Proportion of patients having developed early (≤ day 7) or late (> day 7) VAP in ICU according to the ATS definition(max 60 days)
- Proportion of patients developing ventilator-associated events (VAE) according to the CDC definition(max 60 days)
- ICU length-of-stay(max 60 days)