학술논문

Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis
Document Type
article
Source
Journal of Cardiothoracic Surgery, Vol 16, Iss 1, Pp 1-6 (2021)
Subject
Digital chest drainage
Water-seal chest drainage
Video-assisted thoracic surgery (VATS)
Air leakage
Postoperative complications
Surgery
RD1-811
Anesthesiology
RD78.3-87.3
Language
English
ISSN
1749-8090
Abstract
Abstract Background The usefulness of digital chest drain is still debated. We are carrying out a study to determine if the use of a digital system compared with a traditional system reduces the duration of chest drainage. To evaluate safety, benefit, or futility of this trial we planned the current interim analysis. Methods An interim analysis on preliminary data from ongoing investigator-initiated, multicenter, interventional, prospective randomized trial. Original protocol number: (NCT03536130). The interim main endpoint was overall complications; secondary endpoints were the concordance between the two primary endpoints of the RCT (chest tube duration and length of hospital stay). We planned the interim analysis when half of the patients have been randomised and completed the study. Data were described using mean and standard deviation or absolute frequencies and percentage. T-test for unpaired samples, Chi-square test, Poisson regression and absolute standardized mean difference (ASMD) were used. P-value