ClinicalTrials.gg
CompletedNCT01864577Updated May 29, 2013

Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma

An interventional study of Negative Pleural Suction at -20 cm H2O and Water seal in Hemothorax, Pneumothorax and Hemopneumothorax, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemothorax
  • Pneumothorax
  • Hemopneumothorax
  • Chest Injury Trauma Blunt
  • Chest Injury Trauma
  • Chest Injury Penetrating Wound
03

In context

Hemothorax

26 studies on the registry are indexed under Hemothorax; 5 are open to participants now.

This study's enrollment of 110 is close to the median of 100 across 21 interventional studies indexed under Hemothorax.

Browse Hemothorax studies →

Lead sponsor

Universidad de Antioquia is the lead sponsor of 80 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Invasive mechanical ventilation
  • Emergent Surgery (thoracoscopy, open thoracotomy)
  • Chronic pulmonary diseases (, CRPD)
  • Severe traumatic brain injury
  • Glasgow coma scale upon arrival \<8/15
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    With negative pleural suction

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

    Other: Negative Pleural Suction at -20 cm H2O · Other: Water seal

  • Active comparator
    With water seal

    Patients al left on water seal only

    Other: Water seal

Interventions

  • OtherNegative Pleural Suction at -20 cm H2O
  • OtherWater seal
06

What researchers measure

Primary outcomes

  1. Lenght of Hospital stay

    Time frame: 30 days

Secondary outcomes

  1. Incidence of persistent bronchopleural fistulae

    Time frame: 30 days

  2. Incidence of coagulated Hemothorax

    Time frame: 30 days

  3. Incidence of empyema

    Time frame: 30 days

  4. Incidence of recurrent pneumothorax

    Time frame: 30 days

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

    Time frame: 30 days

07

Study locations

1 site
  • Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario
    Medellin, Antioquia, Colombia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2012, a primary completion of Nov 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2013
First posted
May 29, 2013
Start
Mar 2012
Primary completionActual
Nov 2012
CompletionActual
Nov 2012
Last update
May 29, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01864577
Lead sponsor
Universidad de Antioquia
Collaborators
Hospital San Vicente Fundación
Responsible party
Camila Mejia (Surgical Resident, Universidad de Antioquia) — Principal investigator
First posted
May 29, 2013
Start date
Mar 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
May 29, 2013

Study contacts

Camila Mejia, Resident, General Surgery
principal investigator · Universidad de Antioquia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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