Suction on Post-Operative Chest Tubes

Not Applicable

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Device: Suction is set to -10 cmH2O; Device: Suction is set to -2 cmH2O

• Registration Number: NCT02911259
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Primary Completion: 2017-11-14
• Study Completion: 2017-11-14
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Suction is set to -10 cmH2O	Post-operative suction is set to -10 cmH2O (standard treatment).
Group 1	Suction is set to -2 cmH2O	Post-operative suction is set to -2 cmH2O.

Primary Outcome Measures

Name	Time	Method
Chest tube duration through study completion, an average of 3 days.	Through study completion, an average of 3 days.	Time from intraoperative chest tube placement to it's removal.

Secondary Outcome Measures

Name	Time	Method
Number of participants with pneumonia or empyema.	Through study completion, an average of 21 days
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 with other respiratory problems.	Through study completion, an average of 30 days
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.	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.
Length of stay.	Through study completion, an average of 3 days
Number of participants requiring treatment for subcutaneous emphysema.	Through study completion, an average of 14 days
Number of participants requiring readmission for thoracic surgical complications.	Through study completion, an average of 30 days

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark