Pleural Effusions Post Coronary Artery Bypass GraftNCT02147821
Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
A study testing No Pleural Chest Tube in people with Pleural Effusions Post Coronary Artery Bypass Graft, run by University of Calgary at 1 site in Canada.
Trial summary
This prospective randomized controlled trial will examine the efficacy of reducing the number of chest tubes used in the postoperative cardiac surgery patient. Typically used are three chest tubes - two in the mediastinum and one in the pleural space, if opened. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusions Post Coronary Artery Bypass Graft
- What is being tested?
- No Pleural Chest Tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients must be undergoing CABG at our institution with the attempted harvest of a LIMA and/or RIMA
- pleura must be entered in order for patients to be included.
Who cannot join
- cardiac surgery where the pleura is not entered
- previous surgery where the pleura was entered
- other pre-existing pleural diseases or fibrosis
- Patients currently participating in other studies
- Patients presenting with emergent need for bypass
Trial locations and contacts
1 site in 1 country.
About this study
This prospective randomized controlled trial will examine the efficacy of reducing the number of chest tubes used in the postoperative cardiac surgery patient. Typically used are three chest tubes - two in the mediastinum and one in the pleural space, if opened. The investigators propose that removal of the pleural tube will not impact the rates of clinically significant pleural effusions post cardiac surgery. Patients will be randomized into two groups - one receiving the standard three chest tubes (standard), and the other receiving only mediastinal drains (experimental). The primary outcome will be rates of post-operative pleural effusions as determined by defined interventions, including insertion of a chest tube, thoracentesis, or return to the operating room for primary evacuation of pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length of mechanical ventilation, postoperative respiratory status, and presence/size of pleural effusions, as well as readmission for pleural effusion.
- Being tested
- No Pleural Chest Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Pleural Chest TubeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard treatment will be defined as current practice whereby two mediastinal chest tubes are used for drainage, as well as an additional pleural tube if the pleura is opened during surgery. As part of current standard practice, the pleural and mediastinal spaces will be suctioned during the achievement of hemostasis prior to the insertion of chest tubes. |
| Intervention | Experimental | The treatment arm of the study will involve standard placement of the mediastinal tubes with the exclusion of the pleural tube. Receives: Procedure: No Pleural Chest Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural Effusion
Primary outcome is rate of pleural effusions in a 6 week postoperative period of CABG.
Measured: 6 weeks
Secondary outcomes (1)
Postoperative Respiratory Status
Respiratory status will be defined by measurement of oxygen requirement as well as documented levels of incentive spirometry, as well as length of mechanical ventilation in ICU.
Measured: 1 week after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusions Post Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Spooner, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147821
- Sponsor's protocol ID
- REB13-1374
- Status last verified
- May 2018
- First submitted
- 22 May 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02147821
- Acronym / sponsor ID
- REB13-1374
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 May 2014 (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.
This prospective randomized controlled trial will examine the efficacy of reducing the number of chest tubes used in the postoperative cardiac surgery patient. Typically used are three chest tubes - two in the mediastinum and one in the pleural space, if opened. The investigators propose that removal of the pleural tube will not impact the rates of clinically significant pleural effusions post cardiac surgery. Patients will be randomized into two groups - one receiving the standard three chest tubes (standard), and the other receiving only mediastinal drains (experimental). The primary outcome will be rates of post-operative pleural effusions as determined by defined interventions, including insertion of a chest tube, thoracentesis, or return to the operating room for primary evacuation of pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length of mechanical ventilation, postoperative respiratory status, and presence/size of pleural effusions, as well as readmission for pleural effusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard treatment will be defined as current practice whereby two mediastinal chest tubes are used for drainage, as well as an additional pleural tube if the pleura is opened during surgery. As part of current standard practice, the pleural and mediastinal spaces will be suctioned during the achievement of hemostasis prior to the insertion of chest tubes. |
| Intervention | Experimental | Procedure: No Pleural Chest TubeThe treatment arm of the study will involve standard placement of the mediastinal tubes with the exclusion of the pleural tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients must be undergoing CABG at our institution with the attempted harvest of a LIMA and/or RIMA
- pleura must be entered in order for patients to be included.
Key exclusion criteria (5 listed)
- cardiac surgery where the pleura is not entered
- previous surgery where the pleura was entered
- other pre-existing pleural diseases or fibrosis
- Patients currently participating in other studies
- Patients presenting with emergent need for bypass
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 |
|---|---|---|
| No Pleural Chest Tube | Procedure or surgery | Intervention |
Primary outcome
Pleural Effusion
Time frame: 6 weeks
Primary outcome is rate of pleural effusions in a 6 week postoperative period of CABG.
1 secondary outcome
Postoperative Respiratory Status
Time frame: 1 week after CABG
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 4 May 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Pleural Chest Tube in people with Pleural Effusions Post Coronary Artery Bypass Graft, run by University of Calgary at 1 site in Canada.
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 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 4 May 2018. 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 Canada. 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?
Pleural Effusion (time frame: 6 weeks). 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 4 May 2018.