Compareson Between Sedation and No Sedation in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the safety and efficacy of no-sedation compared to daily interruption of sedation (DIS) in mechanically ventilated patients with chronic obstructive pulmonary disease (COPD). Mechanical ventilation is associated with discomfort, anxiety, and agitation, often requiring sedation. However, excessive sedation may worsen outcomes, especially in COPD patients with respiratory failure. This randomized controlled trial will include 100 adult COPD patients admitted to the respiratory ICU and requiring invasive mechanical ventilation. Patients will be randomly assigned into two groups: one managed with daily interruption of sedation and the other managed with a no-sedation protocol. The primary outcome is ventilator-free days, while secondary outcomes include ICU length of stay, complications, difficulty of weaning, and nursing workload.
详细描述
Mechanical ventilation is a stressful experience for critically ill patients, often associated with pain, discomfort, and anxiety due to invasive procedures, environmental factors, and underlying disease. Sedation is commonly used in intensive care units to improve patient comfort and tolerance to mechanical ventilation. However, excessive sedation has been associated with prolonged mechanical ventilation, longer ICU stay, and increased complications.
Daily interruption of sedation (DIS) has been introduced to reduce sedation-related complications and improve outcomes. Recent trends support minimizing sedation and promoting patient comfort using alternative approaches. However, the optimal sedation strategy in patients with chronic obstructive pulmonary disease (COPD) remains unclear, especially in those with hypercapnic respiratory failure, where sedative drugs may worsen respiratory depression.
This study is a prospective randomized controlled trial conducted in the respiratory intensive care unit at Al-Azhar University Hospital, Assiut, Egypt 100 adult patients with COPD exacerbation requiring invasive mechanical ventilation will be enrolled and randomly assigned into two groups:
Group A (control group): Patients will receive sedation using midazolam infusion with daily interruption guided by the Richmond Agitation-Sedation Scale (RASS).
Group B (intervention group): Patients will be managed with a no-sedation protocol. Sedation will only be administered if clinically indicated due to agitation or discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study with no masking. Both participants and investigators are aware of the assigned interventions
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
- •Adult patients (≥18 years old). Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring invasive mechanical ventilation.
- •Previously diagnosed COPD confirmed by post-bronchodilator FEV1/FVC < 70%. Patients admitted to the respiratory intensive care unit (ICU).
排除标准
- •Known allergy to midazolam. Renal impairment. Hepatic impairment. Active malignancy (cancer). Psychiatric disorders. Neurological disorders. Pregnancy.
研究者
Mohamed Anter Elsayed
Resident of Chest Diseases, ALAzher University Hospital, Assiut
Al-Azhar University