Non-small Cell Lung CancerSPOCTNCT02911259
Suction on Post-Operative Chest Tubes
A study testing Suction is set to -2 cmH2O and Suction is set to -10 cmH2O in people with Non-small Cell Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These results, however, are based on traditional drainage systems with water seal and need to be confirmed using digital drainage systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Suction is set to -2 cmH2O and Suction is set to -10 cmH2O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to 14 Nov 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
- Speaks and understands Danish.
- Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.
Who cannot join
- Cannot cooperate or unable to give consent.
- Chronic drain carrier.
- Planned open procedure.
- Planned resection of additional wedge, additional lobe or thoracic wall.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suction on Post-Operative Chest Tubes After Video-Assisted Thoracoscopic Surgery Lobectomy for Presumed or Confirmed Primary Lung Cancer - At Which Level?
The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These results, however, are based on traditional drainage systems with water seal and need to be confirmed using digital drainage systems.
Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10 cmH2O when looking at chest tube duration and complications.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Suction is set to -2 cmH2O, Suction is set to -10 cmH2O
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction is set to -2 cmH2ODevice
Post-operative suction is set to -2 cmH2O (intervention).
Suction is set to -10 cmH2ODevice
Post-operative suction is set to -10 cmH2O (standard treatment).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Post-operative suction is set to -2 cmH2O. Receives: Device: Suction is set to -2 cmH2O |
| Group 2 | Active comparator | Post-operative suction is set to -10 cmH2O (standard treatment). Receives: Device: Suction is set to -10 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube duration through study completion, an average of 3 days.
Time from intraoperative chest tube placement to it's removal.
Measured: Through study completion, an average of 3 days.
Secondary outcomes (8)
Time to removal criteria have been fulfilled up to 24 hours
Chest tubes can be removed when the patient has been mobilized and the air leakage has not superceeded 20 mL/min in 12 hours and fluid production has not superceded 500 mL in 24 hours.
Measured: Duration from the post-operative chest tube has been placed, until it's potential removal.
Number of participants with prolonged air leak
Measured: Through study completion, an average of 7 days
Number of participants requiring treatment for prolonged air leak.
Measured: Through study completion, an average of 14 days
Number of participants requiring treatment for subcutaneous emphysema.
Measured: Through study completion, an average of 14 days
Number of participants with pneumonia or empyema.
Measured: Through study completion, an average of 21 days
Length of stay.
Measured: Through study completion, an average of 3 days
Number of participants with other respiratory problems.
Measured: Through study completion, an average of 30 days
Number of participants requiring readmission for thoracic surgical complications.
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Principal investigator, Bo Laksáfoss Holbek, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo L. Holbek, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletMerete Christensen, MD, Study director, Copenhagen University Hospital, RigshospitaletJesper Ravn, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911259
- Sponsor's protocol ID
- H-15008900
- Acronym
- SPOCT
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2016
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Marshall MB, Deeb ME, Bleier JI, Kucharczuk JC, Friedberg JS, Kaiser LR, Shrager JB. Suction vs water seal after pulmonary resection: a randomized prospective study. Chest. 2002 Mar;121(3):831-5. doi: 10.1378/chest.121.3.831.
PubMed 11888968Cerfolio RJ, Bryant AS. The management of chest tubes after pulmonary resection. Thorac Surg Clin. 2010 Aug;20(3):399-405. doi: 10.1016/j.thorsurg.2010.04.001.
PubMed 20619231Brunelli A, Beretta E, Cassivi SD, Cerfolio RJ, Detterbeck F, Kiefer T, Miserocchi G, Shrager J, Singhal S, Van Raemdonck D, Varela G. Consensus definitions to promote an evidence-based approach to management of the pleural space. A collaborative proposal by ESTS, AATS, STS, and GTSC. Eur J Cardiothorac Surg. 2011 Aug;40(2):291-7. doi: 10.1016/j.ejcts.2011.05.020.
PubMed 21757129Gottgens KW, Siebenga J, Belgers EH, van Huijstee PJ, Bollen EC. Early removal of the chest tube after complete video-assisted thoracoscopic lobectomies. Eur J Cardiothorac Surg. 2011 Apr;39(4):575-8. doi: 10.1016/j.ejcts.2010.08.002. Epub 2010 Sep 15.
PubMed 20833554Cerfolio RJ, Varela G, Brunelli A. Digital and smart chest drainage systems to monitor air leaks: the birth of a new era? Thorac Surg Clin. 2010 Aug;20(3):413-20. doi: 10.1016/j.thorsurg.2010.03.007.
PubMed 20619233Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
PubMed 24906602Holbek BL, Christensen M, Hansen HJ, Kehlet H, Petersen RH. The effects of low suction on digital drainage devices after lobectomy using video-assisted thoracoscopic surgery: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):673-681. doi: 10.1093/ejcts/ezy361.
PubMed 30445572
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suction on Post-Operative Chest Tubes After Video-Assisted Thoracoscopic Surgery Lobectomy for Presumed or Confirmed Primary Lung Cancer - At Which Level?
- ClinicalTrials.gov ID
- NCT02911259
- Acronym / sponsor ID
- SPOCT / H-15008900
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- Feb 2016 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 22 Sep 2016 (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.
The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These results, however, are based on traditional drainage systems with water seal and need to be confirmed using digital drainage systems.
Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10 cmH2O when looking at chest tube duration and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Suction is set to -2 cmH2OPost-operative suction is set to -2 cmH2O. |
| Group 2 | Active comparator | Device: Suction is set to -10 cmH2OPost-operative suction is set to -10 cmH2O (standard treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Speaks and understands Danish.
- Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.
Key exclusion criteria (4 listed)
- Cannot cooperate or unable to give consent.
- Chronic drain carrier.
- Planned open procedure.
- Planned resection of additional wedge, additional lobe or thoracic wall.
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 |
|---|---|---|
| Suction is set to -2 cmH2OPost-operative suction is set to -2 cmH2O (intervention). | Device | Group 1 |
| Suction is set to -10 cmH2OPost-operative suction is set to -10 cmH2O (standard treatment). | Device | Group 2 |
Primary outcome
Chest tube duration through study completion, an average of 3 days.
Time frame: Through study completion, an average of 3 days.
Time from intraoperative chest tube placement to it's removal.
8 secondary outcomes
Time to removal criteria have been fulfilled up to 24 hours
Time frame: Duration from the post-operative chest tube has been placed, until it's potential removal.
Number of participants with prolonged air leak
Time frame: Through study completion, an average of 7 days
Number of participants requiring treatment for prolonged air leak.
Time frame: Through study completion, an average of 14 days
Number of participants requiring treatment for subcutaneous emphysema.
Time frame: Through study completion, an average of 14 days
Number of participants with pneumonia or empyema.
Time frame: Through study completion, an average of 21 days
Length of stay.
Time frame: Through study completion, an average of 3 days
Number of participants with other respiratory problems.
Time frame: Through study completion, an average of 30 days
Number of participants requiring readmission for thoracic surgical complications.
Time frame: Through study completion, an average of 30 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 1 Jul 2026.
- Background: PubMed 11888968Marshall MB, Deeb ME, Bleier JI, Kucharczuk JC, Friedberg JS, Kaiser LR, Shrager JB. Suction vs water seal after pulmonary resection: a randomized prospective study. Chest. 2002 Mar;121(3):831-5. doi: 10.1378/chest.121.3.831.
- Background: PubMed 20619231Cerfolio RJ, Bryant AS. The management of chest tubes after pulmonary resection. Thorac Surg Clin. 2010 Aug;20(3):399-405. doi: 10.1016/j.thorsurg.2010.04.001.
- Background: PubMed 21757129Brunelli A, Beretta E, Cassivi SD, Cerfolio RJ, Detterbeck F, Kiefer T, Miserocchi G, Shrager J, Singhal S, Van Raemdonck D, Varela G. Consensus definitions to promote an evidence-based approach to management of the pleural space. A collaborative proposal by ESTS, AATS, STS, and GTSC. Eur J Cardiothorac Surg. 2011 Aug;40(2):291-7. doi: 10.1016/j.ejcts.2011.05.020.
- Background: PubMed 20833554Gottgens KW, Siebenga J, Belgers EH, van Huijstee PJ, Bollen EC. Early removal of the chest tube after complete video-assisted thoracoscopic lobectomies. Eur J Cardiothorac Surg. 2011 Apr;39(4):575-8. doi: 10.1016/j.ejcts.2010.08.002. Epub 2010 Sep 15.
- Background: PubMed 20619233Cerfolio RJ, Varela G, Brunelli A. Digital and smart chest drainage systems to monitor air leaks: the birth of a new era? Thorac Surg Clin. 2010 Aug;20(3):413-20. doi: 10.1016/j.thorsurg.2010.03.007.
- Background: PubMed 24906602Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
- Derived from this study: PubMed 30445572Holbek BL, Christensen M, Hansen HJ, Kehlet H, Petersen RH. The effects of low suction on digital drainage devices after lobectomy using video-assisted thoracoscopic surgery: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):673-681. doi: 10.1093/ejcts/ezy361.
- Individual participant dataSharing planned: No
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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.
Bo L. Holbek, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Merete Christensen, MD study director
Copenhagen University Hospital, Rigshospitalet
Jesper Ravn, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction is set to -2 cmH2O and Suction is set to -10 cmH2O in people with Non-small Cell Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 Jul 2026. 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 Denmark. 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?
Chest tube duration through study completion, an average of 3 days. (time frame: Through study completion, an average 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 NCT02911259, which also lists 7 linked publications.
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 Jul 2026.