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临床试验/CTRI/2020/09/027984
CTRI/2020/09/027984已完成不适用

Comparison of efficacy of autologous blood patch pleurodesis versus doxycycline pleurodesis in the management of persistent air leak in patients with secondary spontaneous pneumothorax - A randomised control trial

No sponsor1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Autologous blood patch pleurodesis is a cheap,simple, well tolerated procedure with minimal side effects . If efficacy of Autologous blood patch pleurodesis is proven to be better or equal to theDoxycycline pleurodesis, it can be used as the pleurodising agent of choice in secondary spontaneous pneumothorax.

研究概览

简要总结

All patients fulfilling the inclusion criteria will be enrolled after taking informed written consent. The demographic details, clinical findings will be recorded in a predesigned proforma.

Autologous blood patch pleurodesis;

Using an aseptic technique  50 ml of venous blood preferably from the cubital vein will be withdrawn using 50 ml syringe with 18 Gauge needle. The withdrawn blood will be immediately  injected into the intercostal tube to prevent clotting  . No anticoagulation will be added to  the blood  . The chest tube will be kept   elevated 80 cm above   the patients body levelto prevent the intrapleural blood from escaping thechest but allows continuous drainage of air. The patient remains in bed changing the position every 15 minutes for 2 hours in an attempt to distribute the blood evenly throughout the pleural cavity.

 Doxycycline pleurodesis;

Under strict aseptic precautions  20 ml of 1%lignocaine ( after checking sensitivity)will be instilled in order to reduce the pain perception.After 15 minutes Doxycycline 500 mg will be mixed with 50 ml normal saline solution  and will be instilled into the  chest tube slowly  . The chest tube will be clamped and the patient remains in bed changing position every 15 minutes for 2 hours in an attempt to distribute the drug evenly throughout the pleural cavity.

Grades of air leak;

Grade 1;air leak is present only during a forced expiratory effort or cough

Grade 2;air leak present during the expiration

Grade 3; air leak present during the inspiration

Grade 4; continous air leak  during inspiration and expiration.

Patients with non traumatic pneumothorax with the diagnosis confirmed. These patients will be selected and intercostals tube drainage is done and based upon the radiological investigation. It is divided into Primary and Secondary spontaneous pneumothorax. Those patients with primaryspontaneous pneumothorax will be excluded from the study and standard treatment of care will be given. Those patients with secondary spontaneous pneumothorax will be included in studyand after 72 hours ,chest x ray is taken. If the lungs expandedand if the air leak is present ,then the patients will be randomised to Autologous blood patch pleurodesis and Doxycycline pleurodesis. The air leak will be assessed by conventional tubings. Then the patients are reviewed every 24 hours till 7 days If the air leak persists ,the patients are referred for Cardiothoracic surgical department. The outcome will be assessed by another resident from the department of pulmonary medicine.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Age >18 2 Patients with secondary spontaneous pneumothoraxand Persistent Air leak grade 1- 2.

排除标准

  • 1 Previous history of pleurodesis 2 Traumatic spontaneous pneumothorax 3 Patients with underlying haematological disorders- coagulopathies 4 Patients with hypotension and other cardiopulmonary disease 5Known case of allergy to doxycycline .

结局指标

主要结局

Autologous blood patch pleurodesis is a cheap,simple, well tolerated procedure with minimal side effects . If efficacy of Autologous blood patch pleurodesis is proven to be better or equal to theDoxycycline pleurodesis, it can be used as the pleurodising agent of choice in secondary spontaneous pneumothorax.

时间窗: Every day till 7th day after procedure

次要结局

  • The rate of complications after blood patch pleurodesis and doxycycline pleurodesis.(Every day till 7th day after procedure)

研究者

发起方
No sponsor
申办方类型
Other [Not applicable]

研究点 (1)

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