Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)
研究概览
简要总结
The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) < 110 mL.
详细描述
Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number, dose, or type of corticosteroids administered.
Only a limited number of prospective trials involving adults and evaluating the benefits and the dose of corticosteroid therapy prior to extubation have been conducted.The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy for a subset of high-risk patients who had been intubated for > 48 hours and who were undergoing their first elective extubation in an ICU setting.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were > 18 years of age and met the following weaning criteria:
- •Temperature ≤ 38°C for > 8 hours,
- •Discontinuous use of sedatives,
- •Heart rate ≥ 70 and ≤ 130 /min,
- •Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
- •Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio > 200,
- •Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,
- •Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),
- •Minute ventilation ≤ 15 L/min, and
- •Supplemental oxygen was continued to maintain an oxygen saturation > 95% as measured by a pulse oximeter.
排除标准
- •A history of extubation during the same hospitalization
- •Administration of corticosteroids seven days prior to extubation.
研究组 & 干预措施
1
dexamethasone 5mg was administered every 6 hour for 1 day
干预措施: dexamethasone (Oradexon, Nederland) (Drug)
2
dexamethasone 10mg was administered every 6 hour for 1 day
干预措施: dexamethasone (Oradexon, Nederland) (Drug)
结局指标
主要结局
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)
时间窗: 48 hours
次要结局
未报告次要终点