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

Not Applicable

Completed

• Conditions: Traumatic Hemothorax and Pneumothorax
• Interventions: Device: Intercostal drainage

• Registration Number: NCT02344524
• Lead Sponsor: Delhi University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-17
• Last Update Submitted: 2015-01-17
• Study First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Large bore chest drain	Intercostal drainage	Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain
Small bore chest drain	Intercostal drainage	Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain

Primary Outcome Measures

Name	Time	Method
Success rate	7 days (plus or minus 5 days)	Complete drainage of traumatic hemothorax and pneumothorax

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College of Medical Sciences & GTB Hospital; 🇮🇳 New Delhi, Delhi, India