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

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ClinicalTrials.gov Identifier: NCT02344524
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Sunil Kumar, 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.

Condition or disease Intervention/treatment Phase
Traumatic Hemothorax and Pneumothorax Device: Intercostal drainage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Experimental: Small bore chest drain
Intercostal drainage for traumatic hemothorax and pneumothorax using small bore chest drain
Device: Intercostal drainage
Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.

Active Comparator: Large bore chest drain
Intercostal drainage for traumatic hemothorax and pneumothorax using large bore chest drain
Device: Intercostal drainage
Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.




Primary Outcome Measures :
  1. Success rate [ Time Frame: 7 days (plus or minus 5 days) ]
    Complete drainage of traumatic hemothorax and pneumothorax


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: At the time of the intervention ]
    Time taken for inserting the chest drain

  2. Iatrogenic injuries [ Time Frame: At the time of the intervention ]
    Insertion related complications

  3. Resolution time [ Time Frame: 7 days (plus or minus 5 days) ]
    Time taken for complete drainage of traumatic hemothorax and pneumothorax

  4. Wound healing time [ Time Frame: 10 days (plus or minus 5 days) ]
    Time taken for the chest drain site wound to heal

  5. Catheter sepsis [ Time Frame: 7 days (plus or minus 5 days) ]
    Identification of infective organisms from catheter tip based on culture following chest drain removal



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344524


Locations
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India
University College of Medical Sciences & GTB Hospital
New Delhi, Delhi, India, 110095
Sponsors and Collaborators
Delhi University
Investigators
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Principal Investigator: Sunil Kumar, MS Delhi University
Publications of Results:
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Responsible Party: Sunil Kumar, Director Professor & Head, Department of Surgery, Delhi University
ClinicalTrials.gov Identifier: NCT02344524    
Other Study ID Numbers: CTRI/2014/07/004795
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Pneumothorax
Hemothorax
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes