Chest Tube RemovalNCT00873587
Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
A study testing Chest tube pull on inspiration and Expiration in people with Chest Tube Removal, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Tube Removal
- What is being tested?
- Chest tube pull on inspiration and Expiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND
- Have at least one chest tube.
Who cannot join
- Less than 19 years old,
- With interstitial lung disease, OR
- Any patient intubated.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Randomized Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.
- Conditions
- Chest Tube Removal
- Being tested
- Chest tube pull on inspiration, Expiration
- Keywords
- Thoracotomy, Inspiration, Expiration, Chest Tube, pneumothorax, Method of chest tube removal
- Medical subject headings
- Respiratory Aspiration, Death, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tube pull on inspirationProcedure or surgery
Pull chest tube on Inspiration
ExpirationProcedure or surgery
Pull chest tube on Expiration
| Study group | Role | What they receive |
|---|---|---|
| Inspiration | Other | Not described Receives: Procedure: Chest tube pull on inspiration |
| Expiration | Other | Not described Receives: Procedure: Expiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax
Measured: Within 4 hours after chest tube removal
Secondary outcomes (1)
Morbidity
Measured: 4 hours after chest tube removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Tube RemovalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Cerfolio, MD, Principal investigator, University of Alabama at Birmingham, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873587
- Sponsor's protocol ID
- F081016009
- Status last verified
- Sep 2013
- First submitted
- 30 Mar 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal
- ClinicalTrials.gov ID
- NCT00873587
- Acronym / sponsor ID
- F081016009
- Conditions
- Chest Tube Removal
- Keywords
- Thoracotomy, Inspiration, Expiration, Chest Tube, pneumothorax, Method of chest tube removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Apr 2009 (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.
There are two commonly used methods to remove chest tubes following thoracotomy. One is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). There has been considerable discussion among Thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. The investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiration | Other | Procedure: Chest tube pull on inspiration |
| Expiration | Other | Procedure: Expiration |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), AND
- Have at least one chest tube.
Key exclusion criteria (3 listed)
- Less than 19 years old,
- With interstitial lung disease, OR
- Any patient intubated.
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 |
|---|---|---|
| Chest tube pull on inspirationPull chest tube on Inspiration | Procedure or surgery | Inspiration |
| ExpirationPull chest tube on Expiration | Procedure or surgery | Expiration |
Primary outcome
Pneumothorax
Time frame: Within 4 hours after chest tube removal
1 secondary outcome
Morbidity
Time frame: 4 hours after chest tube removal
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 14 Oct 2015.
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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.
Robert J Cerfolio, MD principal investigator
University of Alabama at Birmingham, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest tube pull on inspiration and Expiration in people with Chest Tube Removal, run by University of Alabama at Birmingham 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 2 inclusion and 3 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 14 Oct 2015. 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 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?
Pneumothorax (time frame: Within 4 hours after chest tube removal). 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 14 Oct 2015.