Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ impairment. In order to tolerate this aggressive mechanical support, enhance patient synchrony with the ventilator, and relieve pain and anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of sedation and analgesia may prolong the duration of mechanical ventilation and increase the risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the widespread use of sedation, little information is available concerning the effect of varying the level of sedation on patients' subsequent mental health. We designed a randomized controlled trial to investigate the efficacy of sedation with the goal of maintaining the patient cooperative and interactive compared to the administration of sedation with the goal of maintaining the patient sedated. The first goal will be achieved by a discontinuous injection of a sedative, while the second goal will be achieved by a continuous infusion of the same sedative. In both groups pain relief will be provided in the same fashion with equal endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU stay, as indicated by the time to discharge from the ICU, the time to separation from mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and hospital length of stay. These endpoints will be compared between the two groups.
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
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients requiring mechanical ventilation
排除标准
- •Neurological conditions or neuromuscular disease
- •Chronic renal failure, liver failure
- •Allergy to benzodiazepines or morphine
- •Drug overdose
- •Pregnancy
- •Non-cooperative
- •Treatment with HIV protease inhibitors or erythromycin
- •Refusal of consent
结局指标
主要结局
Anxiety
Depression
Post-traumatic stress disorders (PTSD)
次要结局
- Rates of pulmonary and extra-pulmonary complications Hospital length of stay
- Time to discharge from the Intensive Care Unit
- Time to separation from mechanical ventilation
