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CTRI Number  CTRI/2025/07/091975 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Washing the Chest Cavity with Not Washing in Patients with Blood in the Chest after Injury Treated with a Chest Tube  
Scientific Title of Study   Comparison of the Outcome of Thoracic Cavity Irrigation Versus No Irrigation in Patients of Traumatic Hemothorax Undergoing Tube Thoracostomy: A Randomized Controlled Trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeeshan Khan 
Designation  Senior Resident Academics 
Affiliation  All India Institute of Medical Science Patna 
Address  601 6th Floor Block C Emarat Enclave Nohsa More AIIMS Road Phulwari Sharif Patna
Room No 105 First floor Department of Trauma Surgery and Critical care Trauma Block AIIMS Patna Phulwari Sharif Patna
Patna
BIHAR
801505
India 
Phone  7509359786  
Fax    
Email  khanjeeshan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Kumar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Science Patna 
Address  Room No 105 First floor Department of Trauma Surgery and Critical Care Trauma Block AIIMS Patna

Patna
BIHAR
801505
India 
Phone    
Fax    
Email  dranilk@aiimspatna.org  
 
Details of Contact Person
Public Query
 
Name  Jeeshan Khan 
Designation  Senior Resident Academics 
Affiliation  All India Institute of Medical Science Patna 
Address  601 6th Floor Block C Emarat Enclave Nohsa More AIIMS Road Phulwari Sharif Patna
Room No 105 First floor Department of Trauma Surgery and Critical care Trauma Block AIIMS Patna Phulwari Sharif Patna
Patna
BIHAR
801505
India 
Phone  7509359786  
Fax    
Email  khanjeeshan@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Science Patna 
 
Primary Sponsor  
Name  Jeeshan Khan 
Address  Room No 105 First floor Department of Trauma Surgery and Critical care Trauma Block AIIMS Patna Phulwari Sharif Patna 
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 
Dr Jeeshan Khan  All India Institute Of Medical Science   Room No 105 First floor Department of Trauma Surgery and Critical care Trauma Block AIIMS Patna Phulwari Sharif Patna
Patna
BIHAR 
7509359786

khanjeeshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute Of Medical Science Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S271||Traumatic hemothorax,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Thoracic irrigation  In the no irrigation group of traumatic hemothorax patients undergoing tube thoracostomy, standard chest tube drainage is performed without instilling any additional fluid into the pleural cavity. 
Intervention  Thoracic irrigation  In patients with traumatic hemothorax undergoing tube thoracostomy, thoracic cavity irrigation involves the instillation of 1 liter of warm sterile normal saline (0.9% NaCl) through the chest tube after proper placement. The saline is introduced slowly, either as a single volume or in divided aliquots, and may be allowed to dwell for a few minutes to help loosen residual blood clots. It is then drained passively or with suction, promoting clearance of retained hemothorax and reducing the risk of complications such as empyema or fibrothorax. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  i. Adults aged 18 years or older with confirmed traumatic hemothorax requiring tube thoracostomy.
ii. Patients presenting within 24 hours of injury during the study period.
iii. Patients who provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  iv. Patients requiring immediate thoracotomy or video-assisted thoracoscopic surgery (VATS).
v. Isolated pneumothorax without evidence of hemothorax.
vi. Tube thoracostomy performed more than 24 hours after the initial trauma.
vii. Hemodynamically unstable patients requiring emergency surgical intervention. viii. Patients who had thoracostomy tube placement at another institution prior to transfer.
ix. Patients whose thoracostomy tube is removed within 24 hours of placement.
x. Patients who die within 48 hours of hospital admission.
xi. Patients younger than 18 years of age.
xii. Patients who refuse consent to participate in the study.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of retained hemothorax requiring secondary interventions such as VATS, thrombolysis, or additional tube thoracostomy.   at 1 week, 2 weeks, 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
i. Incidence of retained hemothorax between the two groups.
ii. Duration of hospital stay.
iii. Development of complications such as empyema, fibrothorax, or infection.
 
at 1 week, 2 weeks, 30 days 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The proposed dissertation is a randomized controlled trial evaluating the effectiveness of thoracic cavity irrigation versus no irrigation during tube thoracostomy in patients with traumatic hemothorax. Traumatic hemothorax is a frequent consequence of thoracic trauma and, if inadequately drained, can lead to retained hemothorax and severe complications like empyema, fibrothorax, and the need for secondary interventions such as video-assisted thoracoscopic surgery (VATS). While systematic reviews and observational studies suggest that thoracic irrigation may significantly reduce these complications, there is a paucity of randomized trials, especially in the Indian context where trauma burden is high and access to advanced interventions is often limited.

This study aims to generate robust evidence on the clinical benefits of thoracic irrigation, particularly its ability to reduce retained hemothorax, minimize secondary interventions, shorten hospital stays, and lower healthcare costs. The trial holds particular relevance for resource-constrained settings like rural India and seeks to establish thoracic irrigation as a cost-effective, scalable intervention. The research question addresses whether thoracic irrigation improves patient outcomes compared to no irrigation, and the hypothesis posits that it will lead to significantly better clinical results. The primary objective is to compare the rate of secondary interventions between the two groups, while secondary objectives include evaluating the incidence of retained hemothorax, hospital stay duration, and complication rates. The findings are expected to influence clinical guidelines and improve trauma care practices in both high- and low-resource healthcare systems.

 
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