Negative Pleural Suction for Tube Thoracostomy in Patient... | NCT01864577

Studies
Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

NCT01864577

Sponsor

Universidad de Antioquia

Status

Completed

Last Update Posted

May 29, 2013Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

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

Interventions

Negative Pleural Suction at -20 cm H2O
Water seal

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

May 20, 2013

First Submission Date that Met QC Criteria

May 24, 2013

First Posted Date

May 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2013

Last Update Posted Date

May 29, 2013Estimated

Name	Class
Hospital San Vicente Fundación	OTHER

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With negative pleural suction	Experimental	Patients are put on negative pleural suction at - 20 cm H2O	Other: Negative Pleural Suction at -20 cm H2O Other: Water seal
With water seal	Active Comparator	Patients al left on water seal only	Other: Water seal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Negative Pleural Suction at -20 cm H2O	Other		With negative pleural suction
Water seal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lenght of Hospital stay		30 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of persistent bronchopleural fistulae		30 days
Incidence of coagulated Hemothorax		30 days
Incidence of empyema

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camila Mejia, Resident, General Surgery	Universidad de Antioquia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario		Medellín	Antioquia		Colombia

Condition Browse Module

MeSH Terms

ID	Term
D006491	Hemothorax
D011030	Pneumothorax
D006468	Hemopneumothorax

Ancestor Terms

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided