Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

Not Applicable

Completed

• Conditions: Hemothorax; Pneumothorax; Hemopneumothorax; Chest Injury Trauma Blunt; Chest Injury Trauma; Chest Injury Penetrating Wound
• Interventions: Other: Water seal; Other: Negative Pleural Suction at -20 cm H2O

• Registration Number: NCT01864577
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-24
• Last Update Submitted: 2013-05-24
• Study First Posted: 2013-05-29
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With water seal	Water seal	Patients al left on water seal only
With negative pleural suction	Negative Pleural Suction at -20 cm H2O	Patients are put on negative pleural suction at - 20 cm H2O
With negative pleural suction	Water seal	Patients are put on negative pleural suction at - 20 cm H2O

Primary Outcome Measures

Name	Time	Method
Lenght of Hospital stay	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario; 🇨🇴 Medellin, Antioquia, Colombia