Lung ResectionPhase 4NCT02282462
Study of Postoperative Chest Tube Management
A Phase 4 study testing Reg Pressure, Unreg Pressure and Active Suction (Dig) in people with Lung Resection, run by Yale University at 5 sites in United States.
Trial summary
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Resection
- What is being tested?
- Reg Pressure, Unreg Pressure and Active Suction (Dig)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2014to 18 Dec 2017
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to read, understand, and provide written consent
- Age 18-90
- Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable
Who cannot join
- Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded
- Patients undergoing non-anatomic lung resection only (i.e. wedge resection)
- Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis.
- Patients undergoing pneumonectomy or completion pneumonectomy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015
Beth Israel Deaconess/ Harvard
Boston, Massachusetts, 02215
WellStar Health System - Kennestone
Marietta, Georgia, 30066
Yale University
New Haven, Connecticut, 06519
Valley Health System
Paramus, New Jersey, 07653
About this study
Official title: A Randomized Comparison of Active Suction vs. Passive Chest Tube Drainage and Regulated and Unregulated Pleural Pressure After Anatomic Lung Resection
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection
Read the detailed description
This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.
- Conditions
- Lung Resection
- Being tested
- Reg Pressure, Unreg Pressure, Active Suction (Dig), Active Suction (Trad), Passive Drainage (Dig)
- Keywords
- Chest tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reg PressureOther
Regulated Suction using the Thopaz+ digital chest drainage device
Unreg PressureOther
Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)
Active Suction (Dig)Other
Thopaz+ digital chest drainage device set at -20cmH2O at the patient
Active Suction (Trad)Other
Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
Passive Drainage (Dig)Other
Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")
Passive Drainage (Trad)Other
Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')
| Study group | Role | What they receive |
|---|---|---|
| Reg pressure, Active suction (Dig) | Experimental | Regulated pleural pressure with active suction Receives: Other: Reg Pressure; Other: Active Suction (Dig) |
| Reg pressure, Passive drainage (Dig) | Experimental | Regulated pleural pressure with passive drainage Receives: Other: Reg Pressure; Other: Passive Drainage (Dig) |
| Unreg pressure, Active suction (Trad) | Experimental | Unregulated pleural pressure with active suction Receives: Other: Unreg Pressure; Other: Active Suction (Trad) |
| Unreg pressure, Passive drainage (Trad) | Experimental | Unregulated pleural pressure with passive drainage Receives: Other: Unreg Pressure; Other: Passive Drainage (Trad) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of air leak
Duration until there is no clinically significant air leak by standard criteria (no bubbles during coughing with a traditional device and a ≥6 hour period with no spikes >80 ml/min and an air flow ≤30 ml/min during passive drainage or ≤50 ml/min during active suction)
Measured: up to 7 days
Secondary outcomes (1)
Time till chest tube removal
Duration of time till chest tube is removed. Chest tube will be removed when resolution of air leak and fluid drainage <= 400 ml/day
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung ResectionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Sponsor
- Investigators
- Frank Detterbeck, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282462
- Sponsor's protocol ID
- 1411014891
- Status last verified
- Jun 2020
- First submitted
- 30 Oct 2014
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Active Suction vs. Passive Chest Tube Drainage and Regulated and Unregulated Pleural Pressure After Anatomic Lung Resection
- ClinicalTrials.gov ID
- NCT02282462
- Acronym / sponsor ID
- 1411014891
- Conditions
- Lung Resection
- Keywords
- Chest tube
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- Dec 2014
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 4 Nov 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.
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection
Detailed description
This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reg pressure, Active suction (Dig) | Experimental | Other: Reg Pressure, Other: Active Suction (Dig)Regulated pleural pressure with active suction |
| Reg pressure, Passive drainage (Dig) | Experimental | Other: Reg Pressure, Other: Passive Drainage (Dig)Regulated pleural pressure with passive drainage |
| Unreg pressure, Active suction (Trad) | Experimental | Other: Unreg Pressure, Other: Active Suction (Trad)Unregulated pleural pressure with active suction |
| Unreg pressure, Passive drainage (Trad) | Experimental | Other: Unreg Pressure, Other: Passive Drainage (Trad)Unregulated pleural pressure with passive drainage |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able and willing to read, understand, and provide written consent
- Age 18-90
- Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable
Key exclusion criteria (4 listed)
- Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded
- Patients undergoing non-anatomic lung resection only (i.e. wedge resection)
- Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis.
- Patients undergoing pneumonectomy or completion pneumonectomy
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 |
|---|---|---|
| Reg PressureRegulated Suction using the Thopaz+ digital chest drainage device | Other | Reg pressure, Active suction (Dig), Reg pressure, Passive drainage (Dig) |
| Unreg PressureUnregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) | Other | Unreg pressure, Active suction (Trad), Unreg pressure, Passive drainage (Trad) |
| Active Suction (Dig)Thopaz+ digital chest drainage device set at -20cmH2O at the patient | Other | Reg pressure, Active suction (Dig) |
| Active Suction (Trad)Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device. | Other | Unreg pressure, Active suction (Trad) |
| Passive Drainage (Dig)Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic") | Other | Reg pressure, Passive drainage (Dig) |
| Passive Drainage (Trad)Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal') | Other | Unreg pressure, Passive drainage (Trad) |
Primary outcome
Duration of air leak
Time frame: up to 7 days
Duration until there is no clinically significant air leak by standard criteria (no bubbles during coughing with a traditional device and a ≥6 hour period with no spikes >80 ml/min and an air flow ≤30 ml/min during passive drainage or ≤50 ml/min during active suction)
1 secondary outcome
Time till chest tube removal
Time frame: up to 7 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 26 Jun 2020.
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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.
Frank Detterbeck, MD principal investigator
Yale University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reg Pressure, Unreg Pressure and Active Suction (Dig) in people with Lung Resection, run by Yale University at 5 sites 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 3 inclusion and 4 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 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of air leak (time frame: up to 7 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 26 Jun 2020.