Lung Cancer
Conditions
Brief summary
The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure. In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.
Interventions
PROCEDURESwitching level of suction
Sponsors
The Leeds Teaching Hospitals NHS Trust
Yale University
The University of Hong Kong
Ospedali Riuniti Ancona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to read, understand, and provide written Informed Consent; * Age range of 18-90 years; * Patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. Both open and minimally invasive (thoracoscopic) resections are acceptable.
Exclusion criteria
* if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis * If during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis. * If the subject meets all of the inclusion criteria and none of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of air leak | up to 7 days |
Secondary
| Measure | Time frame |
|---|---|
| 1. Differences in airflow detected during the 4 hours after the pressure level is switched to -8 cmH2O or -20 cmH2O compared to the original pressure level in both groups | up to 5 days |
| Differences in fluid drainage | up to 5 days |
| Duration of chest tube left in the patient (days) | up to 7 days |
| Postoperative length of hospital stay (days) | up to 7 days |
Countries
Italy
Outcome results
None listed