Simple Aspiration versus Drainage for Complete Pneumothorax: A Randomized Noninferiority Trial

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Abstract Rationale Management of first episodes of primary spontaneous pneumothorax remains the subject of debate. Objectives To determine whether first-line simple aspiration is noninferior to first-line chest tube drainage for lung expansion in patients with complete primary spontaneous pneumothorax. Methods We conducted a prospective, open-label, randomized noninferiority trial. Adults aged 18–50 years with complete primary spontaneous pneumothorax (total separation of the lung from the chest wall), recruited at 31 French hospitals from 2009 to 2015, received simple aspiration (n = 200) or chest tube drainage (n = 202) as first-line treatment. The primary outcome was pulmonary expansion 24 hours after the procedure. Secondary outcomes were tolerance of treatment, occurrence of adverse events, and recurrence of pneumothorax within 1 year. Substantial discordance in the numerical inputs used for trial planning and the actual trial rates of the primary outcome resulted in a reevaluation of the trial analysis plan. Measurement and Main Results Treatment failure occurred in 29% in the aspiration group and 18% in the chest tube drainage group (difference in failure rate, 0.113; 95% confidence interval [CI], 0.026–0.200). The aspiration group experienced less pain overall (mean difference, −1.4; 95% CI, −1.89, −0.91), less pain limiting breathing (frequency difference, −0.18; 95% CI, −0.27, −0.09), and less kinking of the device (frequency difference, −0.05; 95% CI, −0.09, −0.01). Recurrence of pneumothorax was 20% in this group versus 27% in the drainage group (frequency difference, −0.07; 95% CI, −0.16, +0.02). Conclusions First-line management of complete primary spontaneous pneumothorax with simple aspiration had a higher failure rate than chest tube drainage but was better tolerated with fewer adverse events. Clinical trial registered with www.clinicaltrials.gov (NCT01008228).

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