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Suction on Post-Operative Chest Tubes (SPOCT)

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Suction is set to -2 cmH2O

Suction is set to -10 cmH2O

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Post-operative suction is set to -2 cmH2O.

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

Outcomes

Primary Outcome Measures

Chest tube duration through study completion, an average of 3 days.

Time from intraoperative chest tube placement to it's removal.

Secondary Outcome Measures

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patient has been mobilized and the air leakage has not superceeded 20 mL/min in 12 hours and fluid production has not superceded 500 mL in 24 hours.

Number of participants with prolonged air leak

Number of participants requiring treatment for prolonged air leak.

Number of participants requiring treatment for subcutaneous emphysema.

Number of participants with pneumonia or empyema.

Length of stay.

Number of participants with other respiratory problems.

Number of participants requiring readmission for thoracic surgical complications.

Full Information

NCT ID

NCT02911259

First Posted

February 23, 2016

Last Updated

April 26, 2018

Sponsor

Rigshospitalet, Denmark

Collaborators

Medela AG

1. Study Identification

Unique Protocol Identification Number

NCT02911259

Brief Title

Suction on Post-Operative Chest Tubes

Acronym

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?

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

November 14, 2017 (Actual)

Study Completion Date

November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Medela AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Post-operative suction is set to -2 cmH2O.

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Suction is set to -2 cmH2O

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Suction is set to -10 cmH2O

Intervention Description

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

Primary Outcome Measure Information:

Title

Chest tube duration through study completion, an average of 3 days.

Description

Time from intraoperative chest tube placement to it's removal.

Time Frame

Through study completion, an average of 3 days.

Secondary Outcome Measure Information:

Title

Time to removal criteria have been fulfilled up to 24 hours

Description

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.

Time Frame

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

Title

Number of participants with prolonged air leak

Time Frame

Through study completion, an average of 7 days

Title

Number of participants requiring treatment for prolonged air leak.

Time Frame

Through study completion, an average of 14 days

Title

Number of participants requiring treatment for subcutaneous emphysema.

Time Frame

Through study completion, an average of 14 days

Title

Number of participants with pneumonia or empyema.

Time Frame

Through study completion, an average of 21 days

Title

Length of stay.

Time Frame

Through study completion, an average of 3 days

Title

Number of participants with other respiratory problems.

Time Frame

Through study completion, an average of 30 days

Title

Number of participants requiring readmission for thoracic surgical complications.

Time Frame

Through study completion, an average of 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo L. Holbek, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Merete Christensen, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jesper Ravn, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11888968

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. doi: 10.1378/chest.121.3.831.

Results Reference

background

PubMed Identifier

20619231

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.

Results Reference

background

PubMed Identifier

21757129

Citation

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.

Results Reference

background

PubMed Identifier

20833554

Citation

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.

Results Reference

background

PubMed Identifier

20619233

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.

Results Reference

background

PubMed Identifier

24906602

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.

Results Reference

background

PubMed Identifier

30445572

Citation

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.

Results Reference

derived

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Suction on Post-Operative Chest Tubes

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