Efficacy of Povidone-Iodine Instillation Via Tunneled Pleural Catheters in Achieving Pleurodesis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Time to Tunneled Pleural Catheter Removal
研究概览
简要总结
The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal.
详细描述
Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting of recurrent pleural effusions. The most common clinical indication is malignant pleural effusion but these can be used in benign pleural effusions as well (such as those due to congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of dyspnea without the need for recurrent procedures.
Despite success at relieving dyspnea, there are problems with the long-term placement of TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a substantial cost burden. Finally, most patients who undergo TPC placement require home drainage by visiting nurses. This is a significant resource utilization and it often requires interruption of a patient's home routines via the visitation requirements.
Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions. When pleurodesis occurs, the TPC may be removed by a simple office procedure.
Pleurodesis, or the act of inducing scarring and obliteration of the potential space between the visceral and parietal pleura where pleural effusions develop, is a different mechanism of providing relief of dyspnea. In the USA in particular, the most common agent used for pleurodesis (talc) is associated with complications such as respiratory failure and adult respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very expensive.
Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+% with Povidone-Iodine. It also has a favorable safety record and is inexpensive.
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 (Participant)
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
- •Requiring Tunneled Catheter Placement for a Pleural Effusion
排除标准
- •Patient with a nonexpandable lung
- •Non-english speaker
研究组 & 干预措施
Malignant Effusion with Pleurodesis
Patients who had a pleural effusion secondary to a malignant etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
干预措施: Povidone-Iodine (Drug)
Benign Effusion with Pleurodesis
Patients who had a pleural effusion secondary to a benign etiology and subsequently underwent tunneled pleural catheter (TPC) placement and had intrapleural Povidone-Iodine administered at time of placement (100mL of 2% solution). They would have nursing care in the recovery area afterwards and home nursing three times weekly.
干预措施: Povidone-Iodine (Drug)
结局指标
主要结局
Time to Tunneled Pleural Catheter Removal
时间窗: 0-6 months
The time (in days) between Tunneled Pleural Catheter (TPC) placement to eventual removal within 6 months
次要结局
- Baseline Borg Dyspnea Index(Baseline)
- Quality of Life Questionnaire at Baseline(Baseline)
- Quality of Life Questionnaire at 6 months(6 months)
- Death(6 months)
- Mechanical Complications(6 months)
- Pain 2 hours after procedure(2 hours after procedure)
- Immediate hemodynamic reactions following betadine administration(0-6 hours after procedure)
- Borg Dyspnea Index at 2 months(2 months)
- Borg Dyspnea Index at 2 weeks(2 weeks)
- Pleurodesis Rate(2 months)
- Borg Dyspnea Index at 6 months(6 months)
- Quality of Life Questionnaire at 2 weeks(2 weeks)
- Baseline Pain(Baseline)
- Pain 6 hours after procedure(6 hours after procedure)
- Infection Rate(6 months)
- Borg Dyspnea Index at 4 months(4 months)
- Quality of Life Questionnaire at 2 months(2 months)
- Quality of Life Questionnaire at 4 months(4 months)