NCT01864577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

8 months

First QC Date

May 20, 2013

Last Update Submit

May 24, 2013

Conditions

HemothoraxPneumothoraxHemopneumothoraxChest Injury Trauma BluntChest Injury TraumaChest Injury Penetrating Wound

Outcome Measures

Primary Outcomes (1)

  • Lenght of Hospital stay

    30 days

Secondary Outcomes (5)

  • 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

Study Arms (2)

With negative pleural suction

EXPERIMENTAL

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

Other: Negative Pleural Suction at -20 cm H2OOther: Water seal

With water seal

ACTIVE COMPARATOR

Patients al left on water seal only

Other: Water seal

Interventions

Negative Pleural Suction at -20 cm H2OOTHER
With negative pleural suction
Water sealOTHER
With negative pleural suctionWith water seal

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pneumothorax after penetrating o blunt chest trauma
  • Hemothorax after penetrating o blunt chest trauma
  • Hemopneumothorax after penetrating o blunt chest trauma
  • Require tube thoracostomy

You may not qualify if:

  • Invasive mechanical ventilation
  • Emergent Surgery (thoracoscopy, open thoracotomy)
  • Chronic pulmonary diseases (COPD, CRPD)
  • Severe traumatic brain injury
  • Glasgow coma scale upon arrival \<8/15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

HemothoraxPneumothoraxHemopneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Camila Mejia, Resident, General Surgery

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Resident

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 29, 2013

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

CO(1)