• Tania Marx, Luc-Marie Joly, Anne-Laure Parmentier, Jean-Baptiste Pretalli, Marc Puyraveau, Jean-Claude Meurice, Jeannot Schmidt, Olivier Tiffet, Gilbert Ferretti, Dominique Lauque, Didier Honnart, Al FreijatFarajFService de pneumologie, Hôpital Nords Franche-Comté, Trévenans, France., Alain Eric Dubart, Romain Genre Grandpierre, Alain Viallon, Dominique Perdu, Pierre Marie Roy, Toufiq El Cadi, Nathalie Bronet, Grégory Duncan, Gilles Cardot, Philippe Lestavel, Frédéric Mauny, and Thibaut Desmettre.
• Service d'accueil des urgences.
• Am. J. Respir. Crit. Care Med. 2023 Jun 1; 207 (11): 147514851475-1485.

AbstractRationale: 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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