Efficacy, Safety and Re-occurrence of Pneumothorax and Hydro-pneumothorax With Talc and Pyodine Pleurodesis: A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- pulse rate
研究概览
简要总结
Abstract:
INTRODUCTION:
Pneumothorax and hydro-pneumothorax are the most common thoracic injuries and poses a risk of serious morbidity.To prevent the lung from collapsing in such condition, pleurodesis procedure is performed either with surgical pleurodesis,or chemical pleurodesis which adheres outside the lung to the inside chest cavity. The common chemicals that are used are bleomycin, tetracycline, minocycline, slurry of talc and povidoneiodine.
In developed countries, the most common chemical agent used is talc, tetracycline derivatives and bleomycin. However, its clinical results depend on the level of collapse of the lung on the affected side.Internationally, for spontaneous pneumothoraces, talc is the best chemical for pleurodesis procedure which is insufflation through thoracoscopy. However its safety is debateable especially in acute respiratory disease after its administrationwhich made it null and vide consequently. Secondly, in developing countries,medical grade talc availability and affordability remains a constraint. The other suitable chemical is Iodopovidone which is inexpensive and widely used as topical antiseptic in many countries. It also hasshown a safe and effective chemical agent for pleurodesis procedure.
OBJECTIVES:
To determine the efficacy, safety and reoccurrence rate of in pneumothorax and hydro-pneumothorax patients after procedure with talc and pyodine pleurodesis: A comparative study.
MATERIALS AND METHOD:
On the basis of inclusion criteria, the selected 104 patients will be grouped (talc and pyodine) through Non probability, purposive sampling method. In each group 52 willing participants will be included without considering the size of pneumothorax. Six readings of each individual participant will be taken (3 before procedure and 3 after procedure for each group) for pulse and respiratory rate, fever, and total counts of leukocyte. Pain will be assessed on analogue scale. The readings will be taken with 8 hours gap apart. Re-occurrence will be determined after 6 months period of the procedure along with complications if any. The results of both groups will be compared for Efficacy, Safety and Re-occurrence of Pneumothorax and Hydro-pneumothorax.
KEYWORDS:
Pyodine pleurodesis, Talc, hydro-pneumothorax, iodopovidone, pleural effusion, pneumothorax, malignant/prevention & control; Pleurodesis/methods; Recurrence
详细描述
Introduction:
Pneumothorax and hydro-pneumothorax are the common thoracic injuries which have a severe risk of morbidity. In such a condition either gas or air remains in pleural cavity, a space between visceral and parietal pleura of lung1or air and fluid both are present where air fluid level can be seen in upright chest x-ray of the patient2. To prevent the lung from collapsing in such condition, pleurodesis procedure is performed with surgical or chemical agents which adheres outside the lung to the inside chest cavity1. In surgical pleurodesis, removal of the parietal pleura is done which is an effective way of getting stable pleurodesis. In chemical pleurodesis, the space between the parietal and visceral layer is closed through chemical to prevent further accumulation of fluid. The common chemicals that are used are bleomycin, tetracycline, minocycline, slurry of talc and povidoneiodine
Rational of the study:
There is a little local knowledge is available for use of pyodine which is as effective as talc. If it is determined then it could be easily used in rural areas of the country with a safety involvement. Through determining the efficacy, safety and reoccurrence of pyodine in compare with talc pleurodesis procedure in pneumothorax and hydro-pneumothorax, in patients accordance with systemic inflammatory response syndrome. If the safety, efficacy and less rate of reoccurrence of pyodine are determined as compared to gold standard talc, it will be help fill in treating patients at a remote area where the facility of talc is not available. (Talc chemical lost its validity within 24 hours)
Objective:
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sex with aged 18 years to 60 years suffering with Pneumothorax and hydro-pneumothorax with lung expanded in chest x-ray.
- •Patients of Hydro-pneumothorax with fluid less than 50 ml /24 hour
- •Patients having chest tube placed and their column is moving
排除标准
- •Patients with broncho-pulmonary fistula will not be a pleurodesis
- •Patients with malignant pleural effusion
- •Patients with thoraco-scopic procedure having done pleurodesis
研究组 & 干预措施
Pre pleurodesis Procedure Fever Pulse rate Respiratory rate Pa
Pre pleurodesis Fever Pulse rate Respiratory rate Pain thresholds total leukocytes procedure 24 hours before 16 hours before 8 hours before
干预措施: PYODINE AND TALC SLURRY (Drug)
After Pleurodesis procedure Fever Pulse rate Respiratory rate
Post pleurodesis Fever Pulse rate Respiratory rate Pain thresholds total leukocytes procdure 24 hours before 16 hours before 8 hours before
干预措施: PYODINE AND TALC SLURRY (Drug)
结局指标
主要结局
pulse rate
时间窗: 3 months
according to systemic inflammatory response syndrome, any inflammation can cause increase in pulse rate but tachycardia can occur due to side effects, so pulse rate will show the effectiveness of agent
respiratory rate
时间窗: 3 months
it shows how much effective can be the chemical according to systemic inflammatory response syndrome
fever
时间窗: 3 months
it will be measured by thermometer scale and will show the efficacy of the agent as slight fever will show good result because of inflammation.It will show that pleurodesis has been successful and the chemical agent has adherent the two pleural surfaces
total leukocyte count
时间窗: 3 month
it will show the protocol of systemic inflammatory response syndrome as total leukocyte count can rise in inflammation
次要结局
未报告次要终点
研究者
Mateen Ahmed Khan
principal investigator
Dow University of Health Sciences