Inhaled Dnase (Pulmozyme®) as a Non-Invasive Treatment of Atelectasis in Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total Chest X Ray Score
研究概览
简要总结
The investigators hypothesized that dornase alpha, administered twice a day (BID) by in-line nebulizer, would improve oxygenation, compliance, and time to extubation in adult patients receiving mechanical ventilation.
详细描述
Background: Lobar or segmental collapse of the lung in mechanically ventilated patients is a relatively common occurrence in the Intensive Care Unit. Available treatments are either labor or time intensive and not highly effective.
Methods: We conducted a randomized, placebo-controlled, double-blind pilot study to determine whether nebulized recombinant human dornase alpha (Pulmozyme, Genentech) improves radiologic and clinical outcomes in ventilated patients with lobar atelectasis. Outcomes of interest were chest radiograph score, oxygenation, lung compliance, and rate of extubation over the first 5 days. The groups consisted of 14 intervention patients and 16 control patients. They were similar with respect to basic demographics, age, gender, and use of therapeutic modalities relating to lung function. Baseline average chest x-ray scores, Pa02/FI02 ratios, and static compliance were not significantly different. Analysis was limited to the first 5 days.
Results: There was a significant improvement in oxygenation for the intervention group at day 5 (p=0.03). There were no significant differences in chest radiograph score, compliance, or rate of extubation. Two patients died in the intervention group, whereas none died in the control group (NS).
Conclusions: These pilot data suggest that inhaled dornase alpha appears to be safe and is associated with improved oxygenation 5 days after initiation of therapy in mechanically ventilated patients compared to placebo. Larger studies are needed to confirm these findings and determine if this intervention decreases ICU morbidity and mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •current ventilator use
- •onset of lobar or whole lung collapse over the previous 12 hours
- •age greater than 18
排除标准
- •quadriplegia or debilitating neuromuscular condition
- •chronic ventilator dependence
- •pneumothorax
- •frank hemoptysis
- •elevated intracranial pressure
- •intracranial bleed
- •pregnancy or active nursing
- •concurrent use of other investigational drugs
- •history of allergy to Pulmozyme®, Chinese Hamster Ovary-derived biologics, or any of the components of the active or placebo formulations.
研究组 & 干预措施
Nebulized saline
patients on mechanical ventilation who were randomized to receive a placebo comparator (vehicle solution for dornase alpha)
干预措施: Saline (Drug)
dornase alpha
patients on mechanical ventilation who were randomly assigned to receive dornase alpha by in-line nebulization
干预措施: Pulmozyme (nebulized dornase alpha) (Drug)
结局指标
主要结局
Total Chest X Ray Score
时间窗: Days 0-30
次要结局
- Oxygenation (Pa02/FI02)(Days 0-30)
- Static Lung Compliance(Days 0-30)
- Time to Extubation(Days 0-30)