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Completed

NCT Number: NCT01864577

Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

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.

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Key information

Conditions

Hemothorax Chest Injury Penetrating Wound Chest Injury Trauma Chest Injury Trauma Blunt Hemopneumothorax Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Pleural Suction at -20 cm H2O

Other

Water Seal

Other

Primary outcomes

  1. Lenght of Hospital stay

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Collaborators

  • Hospital San Vicente Fundación

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 29, 2013
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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