PneumothoraxNCT01810172
Digital Air Leak Monitoring for Patients Undergoing Lung Resection
A study testing Digital pleural drainage system and Dry suction pleura drainage device in people with Pneumothorax and Atelectasis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Atelectasis
- What is being tested?
- Digital pleural drainage system and Dry suction pleura drainage device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jan 2017
- 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 18 or older
- Patients undergoing a lobectomy or segmentectomy
Who cannot join
- Patients under the age of 18
- Patients undergoing pneumonectomy, wedge resection or bullectomy
- Patients who require additional procedures to control intraoperative air leak
- Patients who require mechanical ventilation post-operatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial
Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. This provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.
Read the detailed description
Technology has become a driving force in surgery. From robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. However, new technology comes at a cost to our healthcare system. It is therefore important to ensure that new devices actually improve outcomes. One example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. Unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. Many intra-operative methods have been explored in order to limit this issue with underwhelming success. This is why we are proposing a randomized controlled trial comparing a digital pleural collection system by ATMOS to traditional pleural collection devices by Atrium.
Our research question is: Can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?
- Conditions
- Pneumothorax, Atelectasis
- Being tested
- Digital pleural drainage system, Dry suction pleura drainage device
- Keywords
- lobectomy, segmentectomy, pneumothorax, pleural, digital, air leak
- Medical subject headings
- Pneumothorax, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital pleural drainage systemDevice
Also called ATMOS pleural drainage system
Reusable device with disposable collection system for digital monitoring of air leak.
Dry suction pleura drainage deviceDevice
Also called Oasis dry suction water seal pleural drainage system
Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.
| Study group | Role | What they receive |
|---|---|---|
| Dry suction pleural drainage system | Active comparator | The control group will have their chest tube connected to a dry suction pleural drainage system The intervention will be the dry suction pleural drainage system Receives: Device: Dry suction pleura drainage device |
| Digital pleural drainage system | Experimental | The experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system. Receives: Device: Digital pleural drainage system |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
The primary objective of this study will be the length of hospital stay from the day of surgery until the day of hospital discharge. The average length of hospital stay is 7 days.
A subgroup analysis will be done to determine the impact of a video-assisted operative approach on length of stay and duration of chest tube drainage in comparison to thoracotomy.
Measured: one year
Secondary outcomes (1)
duration of chest tube insertion
The duration of chest tube drainage which will also be measured in days from the time of insertion in the operating room until they are removed.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madelaine Plourde, Nova Scotia Health Authority
- Investigators
- Madelaine M Plourde, MD,MSc,FRCSC, Principal investigator, CDHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810172
- Sponsor's protocol ID
- CDHA-RS/2013-293
- Status last verified
- Jan 2017
- First submitted
- 11 Mar 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01810172
- Acronym / sponsor ID
- CDHA-RS/2013-293
- Conditions
- Pneumothorax, Atelectasis
- Keywords
- lobectomy, segmentectomy, pneumothorax, pleural, digital, air leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Mar 2013 (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.
Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. This provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.
Detailed description
Technology has become a driving force in surgery. From robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. However, new technology comes at a cost to our healthcare system. It is therefore important to ensure that new devices actually improve outcomes. One example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. Unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. Many intra-operative methods have been explored in order to limit this issue with underwhelming success. This is why we are proposing a randomized controlled trial comparing a digital pleural collection system by ATMOS to traditional pleural collection devices by Atrium.
Our research question is: Can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry suction pleural drainage system | Active comparator | Device: Dry suction pleura drainage deviceThe control group will have their chest tube connected to a dry suction pleural drainage system The intervention will be the dry suction pleural drainage system |
| Digital pleural drainage system | Experimental | Device: Digital pleural drainage systemThe experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system. |
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 18 or older
- Patients undergoing a lobectomy or segmentectomy
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients undergoing pneumonectomy, wedge resection or bullectomy
- Patients who require additional procedures to control intraoperative air leak
- Patients who require mechanical ventilation post-operatively
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 |
|---|---|---|
| Digital pleural drainage systemAlso: ATMOS pleural drainage systemReusable device with disposable collection system for digital monitoring of air leak. | Device | Digital pleural drainage system |
| Dry suction pleura drainage deviceAlso: Oasis dry suction water seal pleural drainage systemDisposable dry suction operating system. Collects pleural fluid and monitors for air leak. | Device | Dry suction pleural drainage system |
Primary outcome
length of hospital stay
Time frame: one year
The primary objective of this study will be the length of hospital stay from the day of surgery until the day of hospital discharge. The average length of hospital stay is 7 days. A subgroup analysis will be done to determine the impact of a video-assisted operative approach on length of stay and duration of chest tube drainage in comparison to thoracotomy.
1 secondary outcome
duration of chest tube insertion
Time frame: one year
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 1 Feb 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.
Madelaine M Plourde, MD,MSc,FRCSC principal investigator
CDHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital pleural drainage system and Dry suction pleura drainage device in people with Pneumothorax and Atelectasis, run by Nova Scotia Health Authority 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 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 1 Feb 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 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?
length of hospital stay (time frame: one year). 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 1 Feb 2017.