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
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 |
The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | University College of Medical Sciences & GTB Hospital | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Delhi University |
India,
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
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 |