HemothoraxNCT01864577
Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma
A study testing Negative Pleural Suction at -20 cm H2O and Water seal in people with Hemothorax and Pneumothorax, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hemothorax, Pneumothorax, Hemopneumothorax
- What is being tested?
- Negative Pleural Suction at -20 cm H2O and Water seal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pneumothorax after penetrating o blunt chest trauma
- Hemothorax after penetrating o blunt chest trauma
- Hemopneumothorax after penetrating o blunt chest trauma
- Require tube thoracostomy
Who cannot join
- Invasive mechanical ventilation
- Emergent Surgery (thoracoscopy, open thoracotomy)
- Chronic pulmonary diseases (COPD, CRPD)
- Severe traumatic brain injury
- Glasgow coma scale upon arrival <8/15
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Departamento de Cirugía, Universidad de Antioquia, San Vicente Fundación Hospital Universitario
Medellín, Antioquia
About this study
Official title: Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial
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.
- Conditions
- Hemothorax, Pneumothorax, Hemopneumothorax, Chest Injury Trauma Blunt, Chest Injury Trauma, Chest Injury Penetrating Wound
- Being tested
- Negative Pleural Suction at -20 cm H2O, Water seal
- Medical subject headings
- Hemothorax, Pneumothorax, Hemopneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pleural Suction at -20 cm H2OOther
Water sealOther
| Study group | Role | What they receive |
|---|---|---|
| With negative pleural suction | Experimental | Patients are put on negative pleural suction at - 20 cm H2O Receives: Other: Negative Pleural Suction at -20 cm H2O; Other: Water seal |
| With water seal | Active comparator | Patients al left on water seal only Receives: Other: Water seal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenght of Hospital stay
Measured: 30 days
Secondary outcomes (5)
Incidence of persistent bronchopleural fistulae
Measured: 30 days
Incidence of coagulated Hemothorax
Measured: 30 days
Incidence of empyema
Measured: 30 days
Incidence of recurrent pneumothorax
Measured: 30 days
Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Vicente Fundación
- Responsible party
- Principal investigator, Camila Mejia, Universidad de Antioquia
- Investigators
- Camila Mejia, Resident, General Surgery, Principal investigator, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864577
- Sponsor's protocol ID
- 01UDEACx2013
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Negative Pleural Suction in Tube Thoracostomy for Patients With Penetrating and/or Blunt Chest Trauma: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01864577
- Acronym / sponsor ID
- 01UDEACx2013
- Conditions
- Hemothorax, Pneumothorax, Hemopneumothorax, Chest Injury Trauma Blunt, Chest Injury Trauma, Chest Injury Penetrating Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- Hospital San Vicente Fundación
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With negative pleural suction | Experimental | Other: Negative Pleural Suction at -20 cm H2O, Other: Water sealPatients are put on negative pleural suction at - 20 cm H2O |
| With water seal | Active comparator | Other: Water sealPatients al left on water seal only |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pneumothorax after penetrating o blunt chest trauma
- Hemothorax after penetrating o blunt chest trauma
- Hemopneumothorax after penetrating o blunt chest trauma
- Require tube thoracostomy
Key exclusion criteria (5 listed)
- Invasive mechanical ventilation
- Emergent Surgery (thoracoscopy, open thoracotomy)
- Chronic pulmonary diseases (COPD, CRPD)
- Severe traumatic brain injury
- Glasgow coma scale upon arrival <8/15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pleural Suction at -20 cm H2O | Other | With negative pleural suction |
| Water seal | Other | With negative pleural suction, With water seal |
Primary outcome
Lenght of Hospital stay
Time frame: 30 days
5 secondary outcomes
Incidence of persistent bronchopleural fistulae
Time frame: 30 days
Incidence of coagulated Hemothorax
Time frame: 30 days
Incidence of empyema
Time frame: 30 days
Incidence of recurrent pneumothorax
Time frame: 30 days
Number of patients necessitating surgical interventions (includes new thoracostomy, thoracoscopy and open thoracotomy)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camila Mejia, Resident, General Surgery principal investigator
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pleural Suction at -20 cm H2O and Water seal in people with Hemothorax and Pneumothorax, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenght of Hospital stay (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.