Suction on Post-Operative Chest Tubes (SPOCT)
June 29, 2026 updated by: Bo Laksáfoss Holbek, Rigshospitalet, Denmark
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark, 2100
- Rigshospitalet
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Speaks and understands Danish.
- Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.
Exclusion Criteria:
- Cannot cooperate or unable to give consent.
- Chronic drain carrier.
- Planned open procedure.
- Planned resection of additional wedge, additional lobe or thoracic wall.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Post-operative suction is set to -2 cmH2O.
|
Post-operative suction is set to -2 cmH2O (intervention).
|
|
Active Comparator: Group 2
Post-operative suction is set to -10 cmH2O (standard treatment).
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Post-operative suction is set to -10 cmH2O (standard treatment).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, an average of 3 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
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Duration from the post-operative chest tube has been placed, until it's potential removal.
|
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Number of participants with prolonged air leak
Time Frame: Through study completion, an average of 7 days
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Through study completion, an average of 7 days
|
|
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Number of participants requiring treatment for prolonged air leak.
Time Frame: Through study completion, an average of 14 days
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Through study completion, an average of 14 days
|
|
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Number of participants requiring treatment for subcutaneous emphysema.
Time Frame: Through study completion, an average of 14 days
|
Through study completion, an average of 14 days
|
|
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Number of participants with pneumonia or empyema.
Time Frame: Through study completion, an average of 21 days
|
Through study completion, an average of 21 days
|
|
|
Length of stay.
Time Frame: Through study completion, an average of 3 days
|
Through study completion, an average of 3 days
|
|
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Number of participants with other respiratory problems.
Time Frame: Through study completion, an average of 30 days
|
Through study completion, an average of 30 days
|
|
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Number of participants requiring readmission for thoracic surgical complications.
Time Frame: Through study completion, an average of 30 days
|
Through study completion, an average of 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bo L. Holbek, MD, Rigshospitalet, Denmark
- Study Director: Merete Christensen, MD, Rigshospitalet, Denmark
- Study Chair: Jesper Ravn, MD, Rigshospitalet, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cerfolio 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.
- 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.
- Cerfolio 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.
- Brunelli 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.
- Gottgens 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.
- Pompili 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.
- Holbek 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
November 14, 2017
Study Completion (Actual)
November 14, 2017
Study Registration Dates
First Submitted
February 23, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimated)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-15008900
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.