Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864577
• Other study ID #: 01UDEACx2013
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: May 24, 2013
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: National Institutes of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Injury Penetrating Wound
• Chest Injury Trauma
• Chest Injury Trauma Blunt
• Hemopneumothorax
• Hemothorax
• Pneumothorax
• Thoracic Injuries
• Wounds and Injuries
• Wounds, Penetrating

Intervention

Other:
• Negative Pleural Suction at -20 cm H2O

• Water seal

Locations

Country	Name	City	State
Colombia	Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	San Vicente Fundación Hospital Universitario

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lenght of Hospital stay		30 days	No
Secondary	Incidence of persistent bronchopleural fistulae		30 days	No
Secondary	Incidence of coagulated Hemothorax		30 days	No
Secondary	Incidence of empyema		30 days	No
Secondary	Incidence of recurrent pneumothorax		30 days	No
Secondary	Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)		30 days	No