| 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
|
|
|
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
|
|
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
|
|
|
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.
|
|
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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 |