ASPIRATE Study- Comparison of Efficacy and Analgesic Use During the Therapy of Iatrogenic Pneumothorax Using Pleuralvent™ and Large Bore Chest Tube (16F)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Treatment efficiency
研究概览
简要总结
The aim of this clinical trial is to compare the efficiency and analgesic use in the therapy of iatrogenic Pneumothorax when using the Pleuralvent™ system in comparison with large bore chest tubes (catheter 16F).
详细描述
Rationale:
Pneumothorax is a common, usually invasively treated, disorder. The usual methods of treatment are needle aspiration (14-16 G needles) or chest drainage (16+ F catheters).
A third therapeutic option is the use of small calibre catheters (< 16F). According to some studies, the success rates of these methods are comparable. These catheters have the same success rate as large bore chest tubes and treatment with them is less painful for patients.
The use of Heimlich valves allows for increased patient mobility - or even out-patient treatment.
According to a review by the European Respiratory Society, nowadays there is an availability of systems which are part of advanced intervention techniques. These devices are designed for ease of insertion allowing for the full mobility of patients. It is, however, not clear whether treatment with these new systems is less painful.
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
- Single (Investigator)
盲法说明
Method of closed envelopes
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
- •Iatrogenic pneumothorax indicated for invasive therapy
排除标准
- •Chronic analgesic therapy
- •Contraindications for Pleuralvent™ use
- •Non-compliance of patients
- •Clinically significant hepatopathy (alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 times normal values)
- •Clinically significant renal insufficiency (glomerular filtration < 0.5 ml/kg/min)
- •Allergy to metamizole/tramadol
研究组 & 干预措施
Pleuralvent™
Patients treated with Pleuralvent™ device
干预措施: Pleuralvent™ (Device)
Chest tube
Patients treated with Chest tube
干预措施: Chest tube (Procedure)
结局指标
主要结局
Treatment efficiency
时间窗: up to 10 days of treatment or until the treatment is terminated
Condition with no need for further therapy modes defined as a absence of pneumothorax on chest X-ray
次要结局
- The time to lung re-expansion(up to 10 days of treatment or until the treatment is terminated)
- Analgesic use(up to 10 days of treatment or until the treatment is terminated)
- Subjective pain perception according to Visual Analogue Scale (VAS) scale(up to 10 days of treatment or until the treatment is terminated)
研究者
Milan Sova
MD, Ph.D.
University Hospital Olomouc