Randomized Multicenter Trial of -8cmH2O versus -15cm H2O Intrathoracic Pressure Digital Thoracic Drainage for Air Leaks after Anatomical Pulmonary Resection.

Background: Digital pleural drainage systems are commonly used for chest tube management after lung resection, but the optimal intrathoracic pressure setting for digital pleural drainage systems in patients with air leaks remains unclear.

Methods: The study was a multicenter, prospective, RCT including patients with moderate air leaks (100-1000 mL/min) following segmentectomy or lobectomy. Patients were randomized to group A (physiological pressure mode, -8 cmHO) and group B (-15 cmHO). The primary endpoint was prolonged air leak incidence.

Results: Out of 2379 registered patients, 93 in group A and 106 in group B received the assigned treatment. There was no significant difference in prolonged air leak incidence between the groups (67.7% vs. 60.4%, P=0.303). The duration of air leak, chest tube placement, and postoperative hospital stay were similar (median 6 vs. 5 days, P=0.429; median 7 vs. 7 days, P=0.568; median 9 vs. 9.5 days, P=0.550). The frequency of pleurodesis owing to air leak after postoperative day 5 was 43.0% in group A and 31.1% in group B, respectively (P=0.105). The proportion of respiratory adverse events (grade 2 or higher) was 1.1% in group A and 6.6% in group B, respectively (P=0.069).

Conclusions: Intrathoracic pressure setting did not affect the earlier remission of air leaks. Patients with air leaks after anatomical pulmonary resection may be appropriately managed by adjusting the negative intrathoracic pressure above -8 cmHO according to the state of the patients.