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Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

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ClinicalTrials.gov Identifier: NCT01864577
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Collaborator:
Hospital San Vicente Fundación
Information provided by (Responsible Party):
Camila Mejia, Universidad de Antioquia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemothorax Pneumothorax Hemopneumothorax Chest Injury Trauma Blunt Chest Injury Trauma Chest Injury Penetrating Wound Other: Negative Pleural Suction at -20 cm H2O Other: Water seal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Lenght of Hospital stay [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Incidence of persistent bronchopleural fistulae [ Time Frame: 30 days ]
  2. Incidence of coagulated Hemothorax [ Time Frame: 30 days ]
  3. Incidence of empyema [ Time Frame: 30 days ]
  4. Incidence of recurrent pneumothorax [ Time Frame: 30 days ]
  5. Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy) [ Time Frame: 30 days ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01864577


Locations
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Colombia
Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Hospital San Vicente Fundación
Investigators
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Principal Investigator: Camila Mejia, Resident, General Surgery Universidad de Antioquia

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Responsible Party: Camila Mejia, Surgical Resident, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01864577     History of Changes
Other Study ID Numbers: 01UDEACx2013
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Pneumothorax
Hemothorax
Hemopneumothorax
Thoracic Injuries
Wounds, Penetrating
Wounds and Injuries
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes