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

January 17, 2015 updated by: Sunil Kumar, Delhi University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110095
        • University College of Medical Sciences & GTB Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 7 days (plus or minus 5 days)
Complete drainage of traumatic hemothorax and pneumothorax
7 days (plus or minus 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: At the time of the intervention
Time taken for inserting the chest drain
At the time of the intervention
Iatrogenic injuries
Time Frame: At the time of the intervention
Insertion related complications
At the time of the intervention
Resolution time
Time Frame: 7 days (plus or minus 5 days)
Time taken for complete drainage of traumatic hemothorax and pneumothorax
7 days (plus or minus 5 days)
Wound healing time
Time Frame: 10 days (plus or minus 5 days)
Time taken for the chest drain site wound to heal
10 days (plus or minus 5 days)
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
7 days (plus or minus 5 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delhi University

Investigators

  • Principal Investigator: Sunil Kumar, MS, Delhi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 17, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 17, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRI/2014/07/004795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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