학술논문
Simple Aspiration versus Drainage for Complete Pneumothorax: A Randomized Noninferiority Trial.
Document Type
Academic Journal
Author
Marx T; Service d'accueil des urgences.; Joly LM; Service d'accueil des urgences, Centre hospitalier universitaire de Rouen, Rouen, France.; Parmentier AL; uMETh, and.; Pretalli JB; Centre Investigation Clinique INSERM 1431, Centre hospitalier universitaire de Besançon, Besançon, France.; Puyraveau M; uMETh, and.; Meurice JC; Service de pneumologie, Centre hospitalier universitaire de Poitiers, Poitiers, France.; Schmidt J; Service d'accueil des urgences, Centre hospitalier universitaire de Clermont-Ferrand, Clermont-Ferrand, France.; Tiffet O; Service de chirurgie thoracique and.; Ferretti G; Service de radiologie diagnostic et thérapeutique, Centre hospitalier universitaire de Grenoble, Grenoble, France.; Lauque D; Toulouse III, Paul Sabatier University, Toulouse, France.; Honnart D; Service d'accueil des urgences, Centre hospitalier universitaire de Dijon, Dijon, France.; Al Freijat F; Service de pneumologie, Hôpital Nords Franche-Comté, Trévenans, France.; Dubart AE; Service d'accueil des urgences, Centre hospitalier de Béthune, Béthune, France.; Grandpierre RG; Service d'anesthésie et soins intensifs, Centre hospitalier universitaire de Nîmes, Nîmes, France.; Viallon A; Service d'accueil des urgences, Centre hospitalier universitaire de Saint-Etienne, Saint-Etienne, France.; Perdu D; Service de pneumologie, Centre hospitalier universitaire de Reims, Reims, France.; Roy PM; Service d'accueil des urgences, Centre hospitalier universitaire d'Angers, Angers, France.; El Cadi T; Service d'accueil des urgences, Groupe hospitalier de la Haute-Saône, Vesoul, France.; Bronet N; Service d'accueil des urgences, Centre hospitalier Saint-Philibert-GHICL, Lomme, France.; Duncan G; Service d'accueil des urgences, Centre hospitalier Boulogne-sur-Mer, Boulogne-sur-Mer, France.; Cardot G; Service de chirurgie thoracique, Centre hospitalier Duchenne, Boulogne-sur-Mer, France; and.; Lestavel P; Service de soins intensifs, Polyclinique de Hénin-Beaumont, Hénin-Beaumont, France.; Mauny F; uMETh, and.; Desmettre T; Service d'accueil des urgences.
Source
Publisher: American Thoracic Society Country of Publication: United States NLM ID: 9421642 Publication Model: Print Cited Medium: Internet ISSN: 1535-4970 (Electronic) Linking ISSN: 1073449X NLM ISO Abbreviation: Am J Respir Crit Care Med Subsets: MEDLINE
Subject
Language
English
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).