Manual versus digital aspiration for first-line treatment of primary spontaneous pneumothorax. The AMVADI study: a randomized clinical trial |
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| Institution: | 1. Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain;2. Servicio de Urgencias Generales, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain;3. Servicio de Epidemiología Clínica, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain;1. Servicios de Cirugía Torácica. Hospital Universitario Ramón y Cajal. Madrid. España;2. Servicios de Neumología. Hospital Universitario Ramón y Cajal. Madrid. España;1. Unidad de Gestión Clínica de Urgencias y Medicina Interna, Hospital San Carlos, Cádiz, Spain;2. Unidad de Medicina Pleural, Departamento de Medicina Interna, Hospital Universitario Arnau de Vilanova, IRBLleida, Lleida, Spain;1. Servicio de Neumología, Hospital Universitario y Politécnico La Fe, Valencia, Spain;2. CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain;3. Servicio de Neumología, Hospital Clínic, Barcelona, Spain;1. University of Tunis El Manar, Faculty of Medicine of Tunis, Department of Cardiology, FSI Hospital La Marsa, Tunisia;2. University of Tunis El Manar, Faculty of Medicine of Tunis, Department of Pneumology, FSI Hospital La Marsa, Tunisia;1. Grupo de Investigación de Salud Global, Universidad de Cantabria, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Santander, Cantabria, Spain;2. Servicio de Neumología, Hospital de Laredo, Cantabria, Spain;3. Servicio de Neumología-Debilidad muscular y caquexia en las enfermedades respiratorias crónicas y el cáncer de pulmón, IMIM-Hospital del Mar, Barcelona, Spain;4. Departament de Ciències Experimentals i de la Salut (CEXS), Universitat Pompeu Fabra (UPF), Parc de Recerca Biomèdica de Barcelona (PRBB), Barcelona, Spain;5. Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III (ISCIII), Barcelona, Spain |
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| Abstract: | IntroductionThe effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied. The objective of this research was to compare digital with manual aspiration in a randomized clinical trial.MethodsWe designed a blinded parallel-group randomized clinical trial with a 1:1 allocation ratio. The clinical trial is reported in line with the guidelines of the CONSORT group. The primary outcome variables were immediate success and hospital admission, while the secondary outcome measures were relapse, re-admission and need for surgery, and length of hospital stay. A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration.ResultsA total of 67 patients were included in the study (n = 36, control group; n = 31, experimental group) with no losses to follow-up. In both groups, 58% of procedures were immediately successful, avoiding hospital admission. No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay. Overall, 80% of clinicians who performed aspiration preferred the digital system, and this preference rose to 100% among clinicians who performed more than 5 procedures a year.ConclusionsBoth manual and digital aspiration provide good immediate results avoiding hospital admission, while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax. |
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| Keywords: | Pneumothorax Clinical trial Manual aspiration Digital aspiration Neumotórax Ensayo clínico Aspiración manual Aspiración digital |
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