Thoracic SurgeryNCT00574002
Establishing Safe Drainage Limits for Pleural Chest Tube Removal.
An observational study of Thoracic Surgery and Thoracic Trauma, run by University of Missouri, Kansas City at 1 site in United States.
Trial summary
The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Thoracic Trauma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgery patients
Who may be able to join
- Presence of at least one chest tube
- No air leak present
- Fluid is not infected
- Pleural drainage of fluid was an indication for placement of the chest tube
- Patient is post-thoracic surgery
- Patient is post-thoracic trauma
- Informed consent obtained
Who cannot join
- Presence of air leak
- Infected pleural fluid
- Active intra-thoracic bleeding
- Thoracic empyema
- Non-removal of chest tube (i.e.: expired)
- Pregnancy
- Less than 18 years of age
- Unable to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining the Threshold for Safe Chest Tube Removal.
The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.
Read the detailed description
Measurement of pleural fluid drainage in chest tubes of trauma patients.
- Conditions
- Thoracic Surgery, Thoracic Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients that have their chest tube removed when drainage is 400mL or less in 24 hours. | |
| Group B. | Patients that have their chest tube removed when drainage is 200mL or less in 24 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat chest tube insertion within 30 days
Measured: two years
Thoracotomy on affected side within 30 days
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2009
- Study completionDec 2009
Why it stopped: Low study enrollment; re-evaluating study protocol and study selection criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald L. Early, M.D., M.A., Principal investigator, Truman Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574002
- Sponsor's protocol ID
- 07-68e
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2007
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Threshold for Safe Chest Tube Removal.
- ClinicalTrials.gov ID
- NCT00574002
- Acronym / sponsor ID
- 07-68e
- Conditions
- Thoracic Surgery, Thoracic Trauma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low study enrollment; re-evaluating study protocol and study selection criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Dec 2007 (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 the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.
Detailed description
Measurement of pleural fluid drainage in chest tubes of trauma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients that have their chest tube removed when drainage is 400mL or less in 24 hours. |
| Group B. | – | –Patients that have their chest tube removed when drainage is 200mL or less in 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgery patients
Key inclusion criteria (7 listed)
- Presence of at least one chest tube
- No air leak present
- Fluid is not infected
- Pleural drainage of fluid was an indication for placement of the chest tube
- Patient is post-thoracic surgery
Key exclusion criteria (8 listed)
- Presence of air leak
- Infected pleural fluid
- Active intra-thoracic bleeding
- Thoracic empyema
- Non-removal of chest tube (i.e.: expired)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Repeat chest tube insertion within 30 days
Time frame: two years
Thoracotomy on affected side within 30 days
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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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.
Gerald L. Early, M.D., M.A. principal investigator
Truman Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Thoracic Trauma, run by University of Missouri, Kansas City at 1 site in United States.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Jan 2017. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Repeat chest tube insertion within 30 days (time frame: two years). The study lists 2 primary outcomes in all. 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 9 Jan 2017.