Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain

Study Overview
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Brief Summary
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The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.

Detailed Description
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The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.

Official Title
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Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial

Conditions
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Traumatic Hemothorax and Pneumothorax

Intervention / Treatment
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* Device: Intercostal drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with traumatic hemothorax, pneumothorax and hemopneumothorax Exclusion Criteria: Patients with tension pneumothorax Patients requiring emergency thoracotomy Patients who had undergone chest drain insertion elsewhere Patients lost to follow up

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small bore chest drain<br>Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain | Device: Intercostal drainage<br>* Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.<br>|
| Active Comparator: Large bore chest drain<br>Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain | Device: Intercostal drainage<br>* Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Complete drainage of traumatic hemothorax and pneumothorax | 7 days (plus or minus 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Time taken for inserting the chest drain | At the time of the intervention | 
| Iatrogenic injuries | Insertion related complications | At the time of the intervention | 
| Resolution time | Time taken for complete drainage of traumatic hemothorax and pneumothorax | 7 days (plus or minus 5 days) | 
| Wound healing time | Time taken for the chest drain site wound to heal | 10 days (plus or minus 5 days) | 
| Catheter sepsis | Identification of infective organisms from catheter tip based on culture following chest drain removal | 7 days (plus or minus 5 days) |