| 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
|
|
|
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
|
|
|
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. |