Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

NCT ID: NCT01864577

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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With negative pleural suction

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

Group Type EXPERIMENTAL

Negative Pleural Suction at -20 cm H2O

Intervention Type OTHER

Water seal

Intervention Type OTHER

With water seal

Patients al left on water seal only

Group Type ACTIVE_COMPARATOR

Water seal

Intervention Type OTHER

Interventions

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Negative Pleural Suction at -20 cm H2O

Intervention Type OTHER

Water seal

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Vicente Fundación

OTHER

Sponsor Role collaborator

Universidad de Antioquia

OTHER

Sponsor Role lead

Responsible Party

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Camila Mejia

Surgical Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camila Mejia, Resident, General Surgery

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

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

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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01UDEACx2013

Identifier Type: -

Identifier Source: org_study_id

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