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
|
|
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
|
|
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. |