Comparison of efficacy of patients own blood pleurodesis versus doxycycline pleurodesis in the management of persistent air leak in patients with secondary spontaneous pneumothorax

Completed

• Conditions: Other pneumothorax and air leak,

• Registration Number: CTRI/2020/09/027984
• Lead Sponsor: No sponsor

Brief Summary

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Using an aseptic technique  50 ml of venous blood preferably from the cubital vein will be withdrawn using 50 ml syringe with 18 Gauge needle. The withdrawn blood will be immediately  injected into the intercostal tube to prevent clotting  .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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Study Completion: 2021-03-05
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

Exclusion Criteria

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 .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Every day till 7th day after procedure

Secondary Outcome Measures

Name	Time	Method
The rate of complications after blood patch pleurodesis and doxycycline pleurodesis.	Every day till 7th day after procedure

Trial Locations

Locations (1)

Jawaharlal Institute of Postgraduate Medical Education and Research; 🇮🇳 Pondicherry, PONDICHERRY, India

Jawaharlal Institute of Postgraduate Medical Education and Research

🇮🇳Pondicherry, PONDICHERRY, India

Dr Vishnukanth G

Principal investigator

9894365158

vishnu1429@yahoo.com