Non-small Cell Lung Cancer
Conditions
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.
Interventions
DEVICESuction is set to -2 cmH2O
Post-operative suction is set to -2 cmH2O (intervention).
DEVICESuction is set to -10 cmH2O
Post-operative suction is set to -10 cmH2O (standard treatment).
Sponsors
Rigshospitalet, Denmark
Medela AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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patient has been mobilized and the air leakage has not superceeded 20 mL/min in 12 hours and fluid production has not superceded 500 mL in 24 hours. |
| 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 | — |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORBo L. Holbek, MD
Rigshospitalet, Denmark
STUDY_DIRECTORMerete Christensen, MD
Rigshospitalet, Denmark
STUDY_CHAIRJesper Ravn, MD
Rigshospitalet, Denmark
Outcome results
None listed