Pulmonary Air LeakDiVA Phase IINCT01775657
Digital Versus Analog Pleural Drainage Following Pulmonary Resection
A study testing Thopaz (Digital drainage) and Pleur Evac (Analogue drainage) in people with Pulmonary Air Leak and Lobectomy, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Air Leak, Lobectomy, Wedge Resection
- What is being tested?
- Thopaz (Digital drainage) and Pleur Evac (Analogue drainage)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to 1 Dec 2021
- 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
- Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease
Who cannot join
- Development of tension pneumothorax
- Pneumonectomy
- Patient no longer within planned randomization window
- Plan to remove or removal of all chest drains within 36 hours of surgery
- Inability to provide informed consent
- Age < 18 years
- Patient was previously randomized following pulmonary resection
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.
Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.
Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.
- Conditions
- Pulmonary Air Leak, Lobectomy, Wedge Resection, Segmentectomy
- Being tested
- Thopaz (Digital drainage), Pleur Evac (Analogue drainage)
- Keywords
- pulmonary air leak, Thopaz, digital, analog, randomized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thopaz (Digital drainage)Device
Also called Thopaz, Medela Switzerland
Pleur Evac (Analogue drainage)Device
Also called Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA
| Study group | Role | What they receive |
|---|---|---|
| Air leak present - Analogue | Experimental | Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present. Receives: Device: Pleur Evac (Analogue drainage) |
| Air leak absent - Analogue (Pleur Evac) | Active comparator | Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present Receives: Device: Pleur Evac (Analogue drainage) |
| Air leak present - Digital (Thopaz) | Experimental | Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system. Receives: Device: Thopaz (Digital drainage) |
| Air leak absent - Digital (Thopaz) | Active comparator | Patients randomized to digital system, no air leak present. Receives: Device: Thopaz (Digital drainage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall length of hospitalization
Measured: Up to 5 days post-op (average)
Secondary outcomes (1)
Time to first pleural drain removal
Measured: Over 24 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Air LeakStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Gilbert, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775657
- Sponsor's protocol ID
- 20120228-01H
- Acronym
- DiVA Phase II
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2012
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.
PubMed 26409729
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Versus Analog Pleural Drainage Following Pulmonary Resection
- ClinicalTrials.gov ID
- NCT01775657
- Acronym / sponsor ID
- DiVA Phase II / 20120228-01H
- Conditions
- Pulmonary Air Leak, Lobectomy, Wedge Resection, Segmentectomy
- Keywords
- pulmonary air leak, Thopaz, digital, analog, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 25 Jan 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.
This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.
Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.
Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Air leak present - Analogue | Experimental | Device: Pleur Evac (Analogue drainage)Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present. |
| Air leak absent - Analogue (Pleur Evac) | Active comparator | Device: Pleur Evac (Analogue drainage)Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present |
| Air leak present - Digital (Thopaz) | Experimental | Device: Thopaz (Digital drainage)Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system. |
| Air leak absent - Digital (Thopaz) | Active comparator | Device: Thopaz (Digital drainage)Patients randomized to digital system, no air leak present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease
Key exclusion criteria (7 listed)
- Development of tension pneumothorax
- Pneumonectomy
- Patient no longer within planned randomization window
- Plan to remove or removal of all chest drains within 36 hours of surgery
- Inability to provide informed consent
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 |
|---|---|---|
| Thopaz (Digital drainage)Also: Thopaz, Medela Switzerland | Device | Air leak absent - Digital (Thopaz), Air leak present - Digital (Thopaz) |
| Pleur Evac (Analogue drainage)Also: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA | Device | Air leak absent - Analogue (Pleur Evac), Air leak present - Analogue |
Primary outcome
Overall length of hospitalization
Time frame: Up to 5 days post-op (average)
1 secondary outcome
Time to first pleural drain removal
Time frame: Over 24 hours post-op
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 21 Nov 2022.
- Derived from this study: PubMed 26409729Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Air Leak
Not yet recruiting
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Surgical Procedures, Operative
Not yet recruitingPhase 2
Effectiveness of Dextrose Pleurodesis for the Management of Post-Operative Air Leak
Post Operative Pulmonary Air Leak
RecruitingObservational study
Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy
Air Leak From Lung, Lung Surgery
Recruiting
Air Leak Detection and Treatment
Air Leak From Lung
Recruiting
Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC
Non-Small Cell Lung Cancer, Postoperative Air Leak
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.
Sebastien Gilbert, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thopaz (Digital drainage) and Pleur Evac (Analogue drainage) in people with Pulmonary Air Leak and Lobectomy, run by Ottawa Hospital Research Institute 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 1 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 21 Nov 2022. 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 length of hospitalization (time frame: Up to 5 days post-op (average)). 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 NCT01775657, which also lists 1 linked publication.
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 21 Nov 2022.