The role of clamping before removal of a chest tube in post-surgical and pneumothorax patients using digital drainage systems: a noninferiority randomised trial.

Introduction: Digital drainage devices have revolutionised chest tube management by providing continuous and objective measurements of air leaks. However, clamping trials remain common practice, influenced by expert opinion, concerns about recurrent pneumothorax and a lack of prospective evidence. This study evaluates whether chest tube removal based solely on digital drainage data is as effective and safe as traditional clamping trials in patients with post-lung surgery or pneumothorax. Methods: In this single-centre, open-label, non-inferiority study, 92 adult patients were randomised to either a No-Clamping Group (intervention) or a clamping trial group (control). The primary outcome was chest tube reinsertion within 24 h due to recurrent ipsilateral pneumothorax. Results: 92 patients were randomised, of whom 83 were included in the per-protocol analysis. The majority of cases were post-operative after pulmonary resection surgery. Chest tube reinsertion within 24 h occurred in 0 of 44 Clamping Group patients (0.0%) and in one of 39 No-Clamping Group patients (2.6%) (risk difference 2.6 percentage points; 95% CI -2.4-7.5), meeting the non-inferiority margin. In six (13.6%) Clamping Group patients, clamping led to progressive pneumothorax, requiring resumed drainage. Secondary outcomes including the total pneumothorax incidence within 24 h and 30 days, chest tube duration and hospital stay were comparable. Conclusion: This study shows that chest tube removal guided solely by digital drainage systems is not inferior to the traditional clamping method in preventing recurrent pneumothorax, supporting the safety of this approach. In a notable proportion of patients, clamping resulted in progression of pneumothorax and prolongation of drainage.