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CTRI Number  CTRI/2018/05/014288 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On: 14/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Protocol based management of chest tubes in thoracic(chest) surgeries. 
Scientific Title of Study   Prospective study to evaluate the role of protocol based management of chest tubes in patients undergoing elective thoracic surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ajit Singh Oberoi 
Designation  Post Graduate Student 
Affiliation  All India Institute Of Medical Sciences 
Address  Room no 5035, academics block, department of surgical disciplines, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9990380952  
Fax    
Email  ajitaiimsz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajinder Parshad 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Room no 5035, academics block, department of surgical disciplines, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9868397715  
Fax    
Email  drrajinderparshad.aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajinder Parshad 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Room no 5035, academics block, department of surgical disciplines, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9868397715  
Fax    
Email  drrajinderparshad.aiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences,Ansari Nagar, New Delhi-110029 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  Ansari Nagar, New Delhi-110029 
Type of Sponsor  Research institution and hospital 
 
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 
Ajit Singh Oberoi  All India Institute Of Medical Sciences  Department of Surgical Disciplines, Academic Block,Ansari Nagar, New Delhi-110029
South
DELHI 
9990380952

ajitaiimsz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee For Post Graduate Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective thoracic surgery with chest tubes placed at the end of the procedure that consent to participate in the study. 
 
ExclusionCriteria 
Details  Patients likely to require mechanical ventilation/prolonged intubation beyond POD 0
Re operative thoracic surgery.
Patients planned for pneumonectomy.
Patients undergoing esophageal resections.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Duration of chest tubes in elective thoracic surgery  Day of removal of ICD 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of post operative stay.
Chest tube re-insertions following chest tube removal within 30 days.
 
Till 30 days from removal of ICD 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2016 
Date of Study Completion (India) 31/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
No Study Till Date 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Drainage of the pleural space has been practiced since the time of hippocrates and chest tubes have been routinely used to drain the pleural space particularly after lung surgery. However, despite being used for long time in thoracic surgeries, there is no definitive consensus over its management. Chest tube management has been determined primarily by the tradition and personal experience of the surgical team rather than a scientifically validated management protocol. There is wide variation in clinical practice regarding the size and number of chest tubes to be inserted, the timing of removal of chest tubes, and management of chest tube in presence of minimal air leaks and ongoing drainage of pleural fluid. Further there is no consensus on the volume of pleural fluid draining at which a chest tube can be removed safely. 

 Air leak is one of the most common complications after pulmonary resection. Conventional teaching favors chest tube to be retained till air leak stops completely and there is pleura to pleura apposition. However recent studies suggested that it may be possible to discharge a patient with minimum air leak and non expanding residual pneumothorax if patient is stable.   Recent work by cerfolio et al suggest early discharge of patients with air leak is possible with Heimlich valve.

 The other common cause for which chest tubes are retained for prolonged duration is persistent drainage of pleural fluid. This also has been shown to be the most common cause of delayed discharge from hospital. Though there is no standard definition of persistent chest drain output, a quantity below 100- 150 ml has long been arbitrarily used below which chest tube removal is considered safe. However many randomized trials advocate a higher drainage criteria ranging from 300ml to as high as 500ml per 24 hours.

 In a large retrospective cohort study by cerfolio et al in 2,077 patients ,no significant difference was found in complication and readmission rates when chest tubes were removed at a drainage of 450 ml as compared to their usual practice of 250 ml.

 Therefore it is evident that air leak and prolonged chest tube drainage are the 2 major reasons for delayed chest tube removal and prolonged postoperative stay. Studies in the recent years have been aiming at early removal of chest tube and shortening the post operative stay using validated protocol based management of chest tubes. These studies have shown that the chest tube removal time can be shortened from 4-5 days to 3 days  in most patients and post operative discharge can be hastened from 7-8 days  to 4-5  days  with protocol based management.  Further it has been shown in the west that patients with minimum air leak and residual stable pleural space can be safely discharged on Heimlich valve . All these studies are from developed nations where majority of pulmonary resections are done for malignancies and emphysematous condition, whereas as in our setup majority of thoracic surgeries are being performed for inflammatory lung diseases where pleural physiology is conceivably different and algorithm developed for non inflammatory conditions should not be indiscriminately applied to our patients.

 This study is being planned with the intent to develop a protocol based management of chest tubes, especially with regard to management of air leaks and chest tube drainage in Indian setting. The ultimate aim is to reduce patient morbidity by decreasing the duration of chest tube and postoperative hospital stay.

RESULTS

Out of 122 patients recruited in study, 53% patients underwent pulmonary resections, and 38% patient underwent surgery for mediastinal pathology. ICD protocol could be followed in 101 patients and 84 patients were discharged according to the protocol. Chest tube dwelling time and postoperative hospital stay was significantly less in patient in whom protocol was followed vis a vis those in whom it could not be followed. Reinsertions were significantly higher in patients in whom protocol could not be followed. No difference in readmissions and mortality was noted. Comparison with data before starting of the study, revealed an early ICD removal and discharge was possible in prospective patients

 
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