Digital Versus Analog Pleural Drainage Following Pulmonary Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Overall length of hospitalization
研究概览
简要总结
This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.
Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.
Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease
排除标准
- •Development of tension pneumothorax
- •Pneumonectomy
- •Patient no longer within planned randomization window
- •Plan to remove or removal of all chest drains within 36 hours of surgery
- •Inability to provide informed consent
- •Age < 18 years
- •Patient was previously randomized following pulmonary resection
研究组 & 干预措施
Air leak present - Analogue
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.
干预措施: Pleur Evac (Analogue drainage) (Device)
Air leak absent - Analogue (Pleur Evac)
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present
干预措施: Pleur Evac (Analogue drainage) (Device)
Air leak present - Digital (Thopaz)
Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.
干预措施: Thopaz (Digital drainage) (Device)
Air leak absent - Digital (Thopaz)
Patients randomized to digital system, no air leak present.
干预措施: Thopaz (Digital drainage) (Device)
结局指标
主要结局
Overall length of hospitalization
时间窗: Up to 5 days post-op (average)
次要结局
- Time to first pleural drain removal(Over 24 hours post-op)