Suction on Post-Operative Chest Tubes

Non-small Cell Lung Cancer Clinical Trial

— SPOCT  

Official title:

Suction on Post-Operative Chest Tubes After Video-Assisted Thoracoscopic Surgery Lobectomy for Presumed or Confirmed Primary Lung Cancer - At Which Level?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911259
• Other study ID #: H-15008900
• Status: Completed
• Phase: N/A
• First received: February 23, 2016
• Last updated: April 26, 2018
• Start date: February 2016
• Est. completion date: November 14, 2017

Study information

• Verified date: April 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Device:
• Suction is set to -2 cmH2O
Post-operative suction is set to -2 cmH2O (intervention).
• Suction is set to -10 cmH2O
Post-operative suction is set to -10 cmH2O (standard treatment).

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Medela AG

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Göttgens 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest tube duration 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	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.	Duration from the post-operative chest tube has been placed, until it's potential removal.
Secondary	Number of participants with prolonged air leak		Through study completion, an average of 7 days
Secondary	Number of participants requiring treatment for prolonged air leak.		Through study completion, an average of 14 days
Secondary	Number of participants requiring treatment for subcutaneous emphysema.		Through study completion, an average of 14 days
Secondary	Number of participants with pneumonia or empyema.		Through study completion, an average of 21 days
Secondary	Length of stay.		Through study completion, an average of 3 days
Secondary	Number of participants with other respiratory problems.		Through study completion, an average of 30 days
Secondary	Number of participants requiring readmission for thoracic surgical complications.		Through study completion, an average of 30 days