Back to results

Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

Primary Purpose

Hemothorax, Pneumothorax, Hemopneumothorax

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

Negative Pleural Suction at -20 cm H2O

Water seal

About this trial

This is an interventional treatment trial for Hemothorax

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With negative pleural suction

With water seal

Arm Description

Patients are put on negative pleural suction at - 20 cm H2O

Patients al left on water seal only

Outcomes

Primary Outcome Measures

Lenght of Hospital stay

Secondary Outcome Measures

Incidence of persistent bronchopleural fistulae

Incidence of coagulated Hemothorax

Incidence of empyema

Incidence of recurrent pneumothorax

Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)

Full Information

NCT ID

NCT01864577

First Posted

May 20, 2013

Last Updated

May 24, 2013

Sponsor

Universidad de Antioquia

Collaborators

Hospital San Vicente Fundación

1. Study Identification

Unique Protocol Identification Number

NCT01864577

Brief Title

Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Antioquia

Collaborators

Hospital San Vicente Fundación

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemothorax, Pneumothorax, Hemopneumothorax, Chest Injury Trauma Blunt, Chest Injury Trauma, Chest Injury Penetrating Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

With negative pleural suction

Arm Type

Experimental

Arm Description

Patients are put on negative pleural suction at - 20 cm H2O

Arm Title

With water seal

Arm Type

Active Comparator

Arm Description

Patients al left on water seal only

Intervention Type

Other

Intervention Name(s)

Negative Pleural Suction at -20 cm H2O

Intervention Type

Other

Intervention Name(s)

Water seal

Primary Outcome Measure Information:

Title

Lenght of Hospital stay

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Incidence of persistent bronchopleural fistulae

Time Frame

30 days

Title

Incidence of coagulated Hemothorax

Time Frame

30 days

Title

Incidence of empyema

Time Frame

30 days

Title

Incidence of recurrent pneumothorax

Time Frame

30 days

Title

Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Camila Mejia, Resident, General Surgery

Organizational Affiliation

Universidad de Antioquia

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Medellin

State/Province

Antioquia

Country

Colombia

12. IPD Sharing Statement

Learn more about this trial

Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

We'll reach out to this number within 24 hrs