FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/09/027984 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 18/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of efficacy of patients own blood pleurodesis versus doxycycline pleurodesis in the management of persistent air leak in patients with secondary spontaneous pneumothorax  
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishnukanth G 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  9894365158  
Fax    
Email  vishnu1429@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishnukanth G 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri Nagar

PONDICHERRY
605006
India 
Phone  9894365158  
Fax    
Email  vishnu1429@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naren chandra V 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Pulmonary Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  9629814490  
Fax    
Email  drnaren00@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 
 
Primary Sponsor  
Name  No sponsor 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishnukanth G  Jawaharlal Institute of Postgraduate Medical Education and Research  Jawaharlal Institute of Postgraduate Medical Education and Research Dhanvantri Nagar
Pondicherry
PONDICHERRY 
9894365158

vishnu1429@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human Studies), JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J938||Other pneumothorax and air leak,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous blood patch pleurodesis  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. 
Comparator Agent  Doxycycline pleurodesis  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. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Age >18
2 Patients with secondary spontaneous pneumothoraxand Persistent Air leak grade 1- 2
 
 
ExclusionCriteria 
Details  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 .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
The rate of complications after blood patch pleurodesis and doxycycline pleurodesis.  Every day till 7th day after procedure 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2020 
Date of Study Completion (India) 03/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
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.

 
Close