Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

May 24, 2013 updated by: Camila Mejia, Universidad de Antioquia

Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial

The purpose of this study is to determine whether the use of negative pleural suction in tube thoracostomy is more effective than water seal alone for the treatment of pneumothorax and/or hemothorax in patients with chest trauma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pneumothorax after penetrating o blunt chest trauma
  • Hemothorax after penetrating o blunt chest trauma
  • Hemopneumothorax after penetrating o blunt chest trauma
  • Require tube thoracostomy

Exclusion Criteria:

  • Invasive mechanical ventilation
  • Emergent Surgery (thoracoscopy, open thoracotomy)
  • Chronic pulmonary diseases (COPD, CRPD)
  • Severe traumatic brain injury
  • Glasgow coma scale upon arrival <8/15

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: With negative pleural suction
Patients are put on negative pleural suction at - 20 cm H2O
Other: Negative Pleural Suction at -20 cm H2O
Other: Water seal
Active Comparator: With water seal
Patients al left on water seal only
Other: Water seal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lenght of Hospital stay
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of persistent bronchopleural fistulae
Time Frame: 30 days
30 days
Incidence of coagulated Hemothorax
Time Frame: 30 days
30 days
Incidence of empyema
Time Frame: 30 days
30 days
Incidence of recurrent pneumothorax
Time Frame: 30 days
30 days
Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Universidad de Antioquia

Collaborators

Hospital San Vicente Fundación

Investigators

  • Principal Investigator: Camila Mejia, Resident, General Surgery, Universidad de Antioquia

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

March 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01UDEACx2013

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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