Suction on Post-Operative Chest Tubes

NCT02911259 | Completed DMC

• 1 other identifier: H-15008900
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time to removal criteria have been fulfilled up to 24 hours

  Duration from the post-operative chest tube has been placed, until it's potential removal.

• Number of participants with prolonged air leak

  Through study completion, an average of 7 days

• Number of participants requiring treatment for prolonged air leak.

  Through study completion, an average of 14 days

• Number of participants requiring treatment for subcutaneous emphysema.

  Through study completion, an average of 14 days

• Number of participants with pneumonia or empyema.

  Through study completion, an average of 21 days

Study Arms (2)

Group 1

EXPERIMENTAL

Post-operative suction is set to -2 cmH2O.

Device: Suction is set to -2 cmH2O

Group 2

ACTIVE COMPARATOR

Post-operative suction is set to -10 cmH2O (standard treatment).

Device: Suction is set to -10 cmH2O

Interventions

Suction is set to -2 cmH2O DEVICE

Post-operative suction is set to -2 cmH2O (intervention).

Group 1

Suction is set to -10 cmH2O DEVICE

Post-operative suction is set to -10 cmH2O (standard treatment).

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speaks and understands Danish.
• Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.

You may not qualify if:

• Cannot cooperate or unable to give consent.
• Chronic drain carrier.
• Planned open procedure.
• Planned resection of additional wedge, additional lobe or thoracic wall.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Medela AG: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (7)

• 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.

  PMID: 11888968 BACKGROUND

• 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.

  PMID: 20619231 BACKGROUND

• 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.

  PMID: 21757129 BACKGROUND

• 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.

  PMID: 20833554 BACKGROUND

• 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.

  PMID: 20619233 BACKGROUND

• 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.

  PMID: 24906602 BACKGROUND

• 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.

  PMID: 30445572 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bo L. Holbek, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Merete Christensen, MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Jesper Ravn, MD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: September 22, 2016
• Study Start: February 1, 2016
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)