EARLY TRACHEOSTOMY VERSUS STANDARD OF CARE, A RANDOMIZED CONTROLLED CLINICAL TRIAL IN PATIENTS WITH SEVERE HEAD INJURY IN MULAGO HOSPITAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- 30day mortality
研究概览
简要总结
Severe head injury is associated with airway compromise and poor respiratory effort. In Mulago Hospital intubation is the mainstay intervention and then patients are subjected to the wait and see strategy of delayed or no tracheostomy, very few undergo early tracheostomy, and some patients are left without an artificial airway.Using endotracheal tubes is associated with complications which have been shown to increase intensive care unit (ICU) and hospital stay, morbidity and mortality.
Tracheostomy has been reported to have advantages over translaryngeal intubation but the optimal timing of tracheostomy in patients with severe head injury is controversial. Studies done elsewhere have showed that patients with severe head injury who undergo early tracheostomy have better survival outcomes but no studies have been done in our setting
详细描述
Introduction; Most patients with severe head injury cannot protect their airway, have excessive secretions and inadequate spontaneous breathing which contributes to cerebral hypoxia. Thus, in their initial management the airway is secured with either an endotracheal tube (ETT) or a tracheostomy. In Mulago Hospital some of these patients are intubated and then subjected to the wait and see strategy of delayed or no tracheostomy, very few undergo early tracheostomy, and some patients are left without an artificial airway. Tracheostomy has been reported to have advantages over translaryngeal intubation but the optimal timing of tracheostomy in patients with severe head injury is controversial. Studies done elsewhere have showed that patients with severe head injury who undergo early tracheostomy have better outcomes.
Problem statement; Mulago hospital receives the largest number of patients with severe head injured with a mortality rate of 69%. Securing these patients airway using ETT is associated with complications which have been shown to increase ICU and hospital stay, morbidity and mortality. Furthermore, most intubated patients often require ICU admission for care of ETT and mechanical ventilation and yet these patients require little or no assistance from mechanical ventilation if the airway has been secured with a tracheostomy. With limited number of ventilators and beds in ICU and increased demand for ICU admission in Mulago hospital, this poses a challenge.
Objective; To compare 30 day mortality of severe head injured patients undergoing early tracheostomy versus standard of care in Mulago Hospital and the associated factors
Methodology; Randomized controlled clinical trial, open label, to be carried out in Mulago Hospital Trauma Centre, casualty, ICU, and neuro-surgical ward high dependence unit (3AHDU).
All patients above 10years with severe traumatic brain injury who meet the study criteria will be recruited and randomly assigned to either arm.
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
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 10years
排除标准
- •Patients who undergo tracheostomies within 24hours of admission before randomization
结局指标
主要结局
30day mortality
时间窗: within 30 days of follow up
the number of deaths recorded within 30days of admission
次要结局
- duration of sedation(30days)
- length of ICU and hospital stay(30 days)
- Glasgow coma scale on discharge(30days)
- incidence of ventilator associated pneumonia(30days)