Suction on Post-Operative Chest Tubes

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Device: Suction is set to -2 cmH2O
* Device: Suction is set to -10 cmH2O


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Post-operative suction is set to -2 cmH2O. | Device: Suction is set to -2 cmH2O<br>* Post-operative suction is set to -2 cmH2O (intervention).<br>|
| Active Comparator: Group 2<br>Post-operative suction is set to -10 cmH2O (standard treatment). | Device: Suction is set to -10 cmH2O<br>* Post-operative suction is set to -10 cmH2O (standard treatment).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| Length of stay. |  | Through study completion, an average of 3 days | 
| Number of participants with other respiratory problems. |  | Through study completion, an average of 30 days | 
| Number of participants requiring readmission for thoracic surgical complications. |  | Through study completion, an average of 30 days |