Back to resultsDrainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain
Primary Purpose
Traumatic Hemothorax and Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intercostal drainage
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Hemothorax and Pneumothorax
Eligibility Criteria
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
Sites / Locations
- University College of Medical Sciences & GTB Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Small bore chest drain
Large bore chest drain
Arm Description
Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain
Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain
Outcomes
Primary Outcome Measures
Success rate
Complete drainage of traumatic hemothorax and pneumothorax
Secondary Outcome Measures
Procedure time
Time taken for inserting the chest drain
Iatrogenic injuries
Insertion related complications
Resolution time
Time taken for complete drainage of traumatic hemothorax and pneumothorax
Wound healing time
Time taken for the chest drain site wound to heal
Catheter sepsis
Identification of infective organisms from catheter tip based on culture following chest drain removal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02344524
Brief Title
Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain
Official Title
Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delhi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Hemothorax and Pneumothorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small bore chest drain
Arm Type
Experimental
Arm Description
Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain
Arm Title
Large bore chest drain
Arm Type
Active Comparator
Arm Description
Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain
Intervention Type
Device
Intervention Name(s)
Intercostal drainage
Intervention Description
Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.
Primary Outcome Measure Information:
Title
Success rate
Description
Complete drainage of traumatic hemothorax and pneumothorax
Time Frame
7 days (plus or minus 5 days)
Secondary Outcome Measure Information:
Title
Procedure time
Description
Time taken for inserting the chest drain
Time Frame
At the time of the intervention
Title
Iatrogenic injuries
Description
Insertion related complications
Time Frame
At the time of the intervention
Title
Resolution time
Description
Time taken for complete drainage of traumatic hemothorax and pneumothorax
Time Frame
7 days (plus or minus 5 days)
Title
Wound healing time
Description
Time taken for the chest drain site wound to heal
Time Frame
10 days (plus or minus 5 days)
Title
Catheter sepsis
Description
Identification of infective organisms from catheter tip based on culture following chest drain removal
Time Frame
7 days (plus or minus 5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Kumar, MS
Organizational Affiliation
Delhi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College of Medical Sciences & GTB Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110095
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
22205619
Citation
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.
Results Reference
result
Learn more about this trial
Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain
We'll reach out to this number within 24 hrs