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

Traumatic Hemothorax and Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344524
• Other study ID #: CTRI/2014/07/004795
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: January 17, 2015
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2015
• Source: Delhi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemothorax
• Pneumothorax
• Traumatic Hemothorax and Pneumothorax

Intervention

Device:
• Intercostal drainage
Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.

Locations

Country	Name	City	State
India	University College of Medical Sciences & GTB Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Delhi University

Country where clinical trial is conducted

India, 

References & Publications (1)

Yi JH, Liu HB, Zhang M, Wu JS, Yang JX, Chen JM, Xu SX, Wang JA. Management of traumatic hemothorax by closed thoracic drainage using a central venous catheter. J Zhejiang Univ Sci B. 2012 Jan;13(1):43-8. doi: 10.1631/jzus.B1100161. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Complete drainage of traumatic hemothorax and pneumothorax	7 days (plus or minus 5 days)	No
Secondary	Procedure time	Time taken for inserting the chest drain	At the time of the intervention	No
Secondary	Iatrogenic injuries	Insertion related complications	At the time of the intervention	Yes
Secondary	Resolution time	Time taken for complete drainage of traumatic hemothorax and pneumothorax	7 days (plus or minus 5 days)	No
Secondary	Wound healing time	Time taken for the chest drain site wound to heal	10 days (plus or minus 5 days)	No
Secondary	Catheter sepsis	Identification of infective organisms from catheter tip based on culture following chest drain removal	7 days (plus or minus 5 days)	No