Manual Versus Digital Aspiration for First-Line Treatment of Primary Spontaneous Pneumothorax. The AMVADI Study: A Randomized Clinical Trial

Abstract

Introduction: The 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.

Methods: We 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.

Results: A 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 5procedures a year.

Conclusions: Both 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.

Keywords: Aspiración digital; Aspiración manual; Clinical trial; Digital aspiration; Ensayo clínico; Manual aspiration; Neumotórax; Pneumothorax.