Prevention of Ventilator-Associated Pneumonia by Oropharyngeal and Subglottic Decontamination Via Bronchoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The incidence of Ventilator-associated Pneumonia
研究概览
简要总结
Ventilator-associated pneumonia (VAP) is common in patients receiving mechanical ventilation, and is associated with longer hospital stay, increased treatment costs, and higher rates of morbidity and mortality . VAP is reported to occur in 8%-67% of mechanically ventilated patients (20%-28% in most reports) and has a mortality rate of 24%-50%, which is 2-3 times the mortality rate of mechanically ventilated patients without VAP. In patients infected by multi-resistant bacteria, the mortality rate may be as high as 76%. The diagnosis, treatment, and prevention of VAP are therefore important. Strategies for preventing VAP are crucial for reducing medical costs and increasing survival rates in critically ill patients. These strategies mainly involve a semi-reclining position with the head of the bed raised to at least 30°-45°, oral care, suctioning of subglottic secretions, selective decontamination of the digestive tract, proper hand washing, avoidance or reduction of proton pump inhibitors, avoidance of excessive sedation, and control of plasma glucose levels.
At our center, VAP is mainly caused by bacterial colonization of the upper respiratory tract via aspiration. This study will compare four interventions including oropharyngeal decontamination and subglottic suctioning by bronchoscopy, with the aim of developing a prevention strategy to minimize the development of VAP during mechanical ventilation.
详细描述
Patients will be assessed as follows:
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Adverse Events:
Adverse events that occur after endotracheal intubation, mechanical ventilation, oral cleansing with chlorhexidine, and suctioning of oropharyngeal secretions by bronchoscopy will be recorded. All adverse events including laboratory abnormalities will be recorded, even if they are thought to be unrelated to medical interventions. The severity of adverse events and any correlations with experimental drugs will be carefully recorded on the case report form.
The relationships between adverse events and drug resistance will be categorized as certainly relevant, probably relevant, possibly relevant, possibly irrelevant, or certainly irrelevant. The proportions of adverse events that are categorized as certainly relevant, probably relevant, and possibly relevant will be calculated. Severe adverse events will be recorded in a table and reported to the director of the unit and the sponsor within 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled for endotracheal intubation and mechanical ventilation.
排除标准
- •Patients who underwent endotracheal intubation or tracheotomy before study enrollment.
- •Patients who underwent endotracheal intubation and mechanical ventilation within 30 days before study enrollment.
- •Patients who require cardiopulmonary resuscitation.
- •Patients with a history of emesis and aspiration before endotracheal intubation.
- •Patients who are judged unsuitable for enrollment by clinicians.
研究组 & 干预措施
Chlorhexidine before intubation
Group A: Oropharyngeal decontamination with chlorhexidine before intubation, n=48. Oral cleansing with chlorhexidine will be performed before endotracheal intubation, and every 6 hours after intubation.
干预措施: Chlorhexidine (Drug)
Chlorhexidine before intubation
Group A: Oropharyngeal decontamination with chlorhexidine before intubation, n=48. Oral cleansing with chlorhexidine will be performed before endotracheal intubation, and every 6 hours after intubation.
干预措施: Endotracheal tube (Device)
Chlorhexidine after intubation
Group B: Oropharyngeal decontamination with chlorhexidine after intubation, n=48. Oral cleansing with chlorhexidine will be performed every 6 hours after endotracheal intubation.
干预措施: Chlorhexidine (Drug)
Chlorhexidine after intubation
Group B: Oropharyngeal decontamination with chlorhexidine after intubation, n=48. Oral cleansing with chlorhexidine will be performed every 6 hours after endotracheal intubation.
干预措施: Endotracheal tube (Device)
Subglottic secretion drainage
Group C: Suctioning of subglottic secretions, n=48. Oral cleansing with chlorhexidine will be performed before endotracheal intubation and every 6 hours after intubation, and fiberoptic bronchoscopy-guided suctioning of subglottic secretions will be performed at 10:00 a.m. every day. The procedure will be as follows:
- Routine cleaning of the bronchoscope.
- Oral or nasal insertion of the bronchoscope (according to the decision of the attending physician based on the patient's condition). Rinsing of the subglottic region with 5-20 mL of chlorhexidine solution followed by suctioning. The rinsing procedure will be repeated 3-5 times.
- Routine cleaning of the bronchoscope. The patient will be monitored during all procedures.
干预措施: Chlorhexidine (Drug)
Subglottic secretion drainage
Group C: Suctioning of subglottic secretions, n=48. Oral cleansing with chlorhexidine will be performed before endotracheal intubation and every 6 hours after intubation, and fiberoptic bronchoscopy-guided suctioning of subglottic secretions will be performed at 10:00 a.m. every day. The procedure will be as follows:
- Routine cleaning of the bronchoscope.
- Oral or nasal insertion of the bronchoscope (according to the decision of the attending physician based on the patient's condition). Rinsing of the subglottic region with 5-20 mL of chlorhexidine solution followed by suctioning. The rinsing procedure will be repeated 3-5 times.
- Routine cleaning of the bronchoscope. The patient will be monitored during all procedures.
干预措施: Fiber bronchoscope (Device)
0.9% sodium chloride injection
Group D: 0.9% sodium chloride injection, n=48. After endotracheal intubation, oral cleansing with normal saline will be performed every 6 hours.
干预措施: 0.9% sodium chloride injection (Drug)
0.9% sodium chloride injection
Group D: 0.9% sodium chloride injection, n=48. After endotracheal intubation, oral cleansing with normal saline will be performed every 6 hours.
干预措施: Endotracheal tube (Device)
结局指标
主要结局
The incidence of Ventilator-associated Pneumonia
时间窗: an expected average of 30 days
Percentage of patients who develop VAP after endotracheal intubation
次要结局
- Length of stay(Until discharge from hospital, an expected average of 30 days)
- Length of intensive care unit stay(an expected average of 30 days)
- Duration of mechanical ventilation(Until the last day of mouthpiece ventilation, an expected average of 30 days)
- Hospital costs(During entire hospitalization, an expected average of 30 days)
- 30-day mortality(An expected average of 30 days)
研究者
Zhuang Ma
Professor
General Hospital of Shenyang Military Region