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Lung NeoplasmsNCT01776372

Comparison of Pleural Drainage Systems on Reducing Pleural Effusion Formation Following Lung Resection

A study testing Medela Thopaz Thoracic Drainage System and Atrium Express Dry Seal Chest Drain in people with Lung Neoplasms and Pleural Effusion, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The chest cavity contains a small amount of fluid (pleural effusion). In normal circumstances this fluid is kept in balance. When surgery is performed on the lung, there can be accumulation of more fluid due to many causes. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Lung Neoplasms, Pleural Effusion
What is being tested?
Medela Thopaz Thoracic Drainage System and Atrium Express Dry Seal Chest Drain
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteCanada
Study dates
Jan 2013to Dec 2013
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be between 18 and 90 years of age
  • Diagnosed with suspected lung cancer or metastatic cancer to the lungs
  • Surgery must include lung resection (Wedge; single or multiple, lobectomy or bi-lobectomy) and mediastinal lymph nodes sampling or dissection
  • Demonstrate an ability for understanding the study procedures
  • Demonstrate willingness to remain on-study for the complete duration
  • Must be able to give informed consent to participate at this study.

Who cannot join

  • Patients undergoing lung resection due to non-malignancy
  • Patients undergoing pneumonectomy
  • Patients treated with neo-adjuvant chemotherapy and/or radiation prior to surgery
  • Patients with previous lung resection on the ipsilateral side
  • Patients with evidence of chronic heart failure (i.e. NYHA class III, IV; current treatment with diuretics for heart failure, and/or LVEF <35%)
  • Patients with chronic renal failure (i.e. estimated CCr of < 50ml/min/m2)
  • Patients with history of or ongoing liver disease, expressed by ascites or previous peritoneal tapping for ascites.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Effect of the Use of a Digital Pleural Drainage System on Reducing Pleural Effusion Formation Following Lung Resection

The chest cavity contains a small amount of fluid (pleural effusion). In normal circumstances this fluid is kept in balance. When surgery is performed on the lung, there can be accumulation of more fluid due to many causes. In order to drain this additional amount of pleural fluid, chest tube(s) are left in the thoracic cage after a lung resection procedure. The investigators are attempting to reduce the amount of pleural fluid production and formation by using a more balanced thoracic drainage system, which adjusts the amount of suction depending on the needs of the patient. That way, the amount of inflammation in the thoracic cage might be smaller, and hence less fluid will be formed. By this, the investigators are hoping that the chest tubes can be removed earlier, and the patients can be discharged faster and will potentially have a lower rate of re-admission to the hospital after surgery due to problems related to the fluid in the thoracic cage.

Read the detailed description

Length of hospital stay after lung surgery depends mainly on duration of chest tube drainage. Patients undergoing lung resection have 1 or 2 chest tubes in the pleural cavity to evacuate air and pleural fluid. Digital drainage systems (recently approved for usage in Canada) offer the advantage of maintaining a stable intrapleural pressure through interactive balancing depending on the needs of the patient. In contrast, the traditional chest tube system offers continuous suctioning and negative pleural pressure, regardless the ongoing needs of the patients. Therefore, usage of digital drainage system (already shown to be beneficial in reducing the duration of air leak after lung resection when compared to the traditional system) may potentially reduce the amount of pleural drainage and hence reduce the duration of chest tube drainage until removal and overall patient's length of stay in hospital.

The following is a proposal for a randomized, controlled trial where patients will be randomized to have either a digital drainage system (intervention group) or non-digital drainage system, a conventional system currently used to drain the pleural space (the control group) after major lung resection for malignancy. The primary outcome of this study is comparing the overall amounts of pleural fluid drainage after major lung resection using two different chest tube drainage systems. Secondary outcomes will include measurement in time (hours) that chest tubes remain in-situ before removal following an operative procedure, and overall reduction in the length of stay (LOS) of patients; 90 days overall mortality and morbidity; occurrence of dyspnea related to the reoccurrence of pleural effusion; clinically significant reintervention needed (thoracocentesis, re-insertion of chest drain(s) and number and type of imaging studies required which are related to potential re-accumulation of pleural effusion); readmission rates within 1 month of discharge; comparison of pleural fluid/plasma protein ratio and inflammatory mediators (IL-6, IL-8, IL-10, IL-1RA, TNF-α) between the two groups, a potential indicator for differences in pleural inflammation and permeability between the two groups.

Being tested
Medela Thopaz Thoracic Drainage System, Atrium Express Dry Seal Chest Drain
Keywords
Drainage, Chest tubes, Randomized Controlled Trial
Medical subject headings
Lung Neoplasms, Pleural Effusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medela Thopaz Thoracic Drainage SystemDevice

  • Atrium Express Dry Seal Chest DrainDevice

Study groups in NCT01776372
Study groupRoleWhat they receive
Digital thoracic drainage systemActive comparatorMedela Thopaz Thoracic Drainage System
Receives: Device: Medela Thopaz Thoracic Drainage System
Non-digital thoracic drainage systemActive comparatorAtrium Express Dry Seal Chest Drain
Receives: Device: Atrium Express Dry Seal Chest Drain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall quantity of pleural effusion (mL)

    Overall amount of pleural effusion drained from patients undergoing lung resection until chest tubes removal, comparing the two systems. Fluid output will be measured and recorded every 8 hours, using a digital (Medela®) Thopaz drainage system or traditional non-digital Express (Atrium®) drainage system and the output will be recorded in milliliters. Chest tubes will be removed whenever the drainage is less than 350ml per 24 hours and when there is no active air leak

    Measured: From one hour after surgery to chest tube removal, estimated duration of 3 days

Secondary outcomes (7)

  1. Time chest tubes remain in-situ

    Measurement of the time (in hours and days) that chest tubes remain in-situ following an operative procedure

    Measured: An expected average of 3 days starting from transfer from OR

  2. Length of hospital stay

    Measured: Estimated to be 4 days from admittance to discharge

  3. Mortality and Morbidity

    Overall mortality and morbidity

    Measured: 90 days of surgery

  4. Occurrence of dyspnea related to the reoccurrence of pleural effusion

    Measured: Estimated to be 4 days from admittance to discharge

  5. Clinically significant reintervention needed

    Clinically significant reintervention needed, including thoracocentesis, re-insertion of chest drain(s) and number and type of imaging studies required which are related to potential re-accumulation of pleural effusion

    Measured: Estimated to be 4 days from admittance to discharge

  6. Readmission to hospital rates

    Measured: Within 1 month of discharge

  7. Comparison of pleural fluid/plasma protein ratio and inflammatory mediators

    Comparison of pleural fluid/plasma protein ratio and inflammatory mediators (IL-6, IL-8, IL-10, IL-1RA, TNF-α) between the two groups, a potential indicator for differences in pleural inflammation and permeability between the two groups

    Measured: Samples to be taken in OR and on days 1, 2, 3 and 4 post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionAug 2013
  4. Study completionDec 2013

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01776372
Sponsor's protocol ID
SJHHPleuralDrainageComparsion
Other IDs
R.P. 12-3800
Status last verified
May 2014
First submitted
21 Jan 2013
Last updated
13 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Medela Thopaz Thoracic Drainage System and Atrium Express Dry Seal Chest Drain in people with Lung Neoplasms and Pleural Effusion, run by McMaster University 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 6 inclusion and 7 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 13 May 2014. 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?

Overall quantity of pleural effusion (mL) (time frame: From one hour after surgery to chest tube removal, estimated duration of 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01776372.

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 13 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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