Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)
研究概览
简要总结
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload.
The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.
详细描述
Multicenter, controlled, prospective randomized open study with blinded assessment of the primary endpoint. Two groups are set up: one experimental group with the control of the cuff pressure by the Nosten® device versus one control group with the manual monitoring of the cuff pressure and inflation of the balloon.
Inclusion: All orotracheally intubated patients for an expected period > 48 hours will be selected. Inclusion will be decided using an algorithm adapted to each center to limit the number of inclusion per month without any biases.
The total number of required insclusion is 500, or 250 / group. This calculation is based on the assumption that a frequency of 25% of patients having at least one VAP in the reference strategy, ensuring a 80% power in the detection by Chi-2 test with a difference 10%. A bilateral risk of first species determined at 5% was considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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 aged ≥18 years
- •Patients admitted in the ICU, mechanically ventilated and whose trachea was intubated by the oral route using tubes with catheter polyvinyl chloride "high-volume low pressure" and of standard shape tubes Intubation indication is decided by the physicians in charge according to the usual criteria of respiratory, neurological and /or hemodynamic failure
- •With an expected duration of mechanical ventilation > 48 hours
排除标准
- •Patients intubated by nasotracheal route
- •Patients with tracheotomy before admission
- •Patients intubated with a polyurethane balloon catheter or a polyvinyl chloride balloon catheter of conical shape
- •Previously intubated patients for > 48 hours before their possible recruitment
- •Moribund patients (terminal illness or care-limiting decision)
- •Minors protected or incapacitated patients
- •Patients with recently diagnosed ENT cancer
- •Patients with facial, thoracic, spinal or upper airway trauma
- •Patients burned, intoxicated by fire fumes or caustic ingestion
- •Patient pregnant or breastfeeding (or with known positive urine pregnancy test before inclusion)
- •Patient intubated with a subglottic suction tube
- •Unaffiliated patients to a social security
- •Patients included in any other scientific study that may interfere with the outcome criteria of this study. This includes any other study on tracheal intubation or mechanical ventilation, if the use of the pressure control device may interfere with its endpoint.
研究组 & 干预措施
1: Nosten® monitoring
One experimental group with the control of the cuff pressure by Nosten® device
干预措施: Nosten® pressure control (it's not an antibiotic, but simple device) (Device)
2: Manual monitoring
One control group with the manual monitoring of the cuff pressure and inflation of the balloon
干预措施: Manual pressure control (Other)
结局指标
主要结局
Reduction of the incidence of VAP as defined according to the criteria of the American Thoracic Society (3 months after inclusion)
时间窗: up to 3 months
To prove that the Nosten® device is more effective than monitoring and manual inflation of the catheter balloon in reducing the occurrence of VAP.
次要结局
- Reduction of clinically suspected Ventilator-Acquired Pneumonia (VAP)(up to 3 months)
- Reduction in the periods of hyper-pressure and under-inflation (as long as the patient is intubated during 3 months after inclusion)(up to 3 months)
- Reduction in the significant early laryngeal and tracheal injuries related to intubation (3 months)(up to 3 months)
- Reduction in the duration of antibiotic therapy administered to patients, if diagnosed with ventilator-aquired-pneumonia (VAP) (3 months)(up to 3 months)
- Reduction in the tracheobronchial bacterial colonization assessed using the bacteriological examination of the tracheal aspiration (as long as the patient is intubated during 3 months after inclusion)(up to 3 months)