Background: The usefulness of digital chest drain is still discussed. 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 <0.05 was considered significant.
Results: From April 2017 to November 2018, out of 317 patients were enrolled by 3 centers, 231 fulfilled inclusion criteria and were randomized. Twenty-two of them dropped out after randomization. Finally, 209 patients were analyzed: among them 94 used the digital device and 115 the traditional one. The overall postoperative complications were 35 (16.8%) including prolonged air leak (1.9%). Mean chest tube duration was 3.6 days (SD=1.8), with no differences between two groups (p=0.203). The overall difference between hospital stay and chest tube duration was 1.4 days (SD=1.4). Air leak at first postoperative day detected by digital and traditional devices predicted increasing in tube duration of 1.6 day (CI 95% 0.8-2.5, p<0.001) and 2.0 days (CI 95% 1.0-3.1, p<0.001), respectively.
Conclusions: This interim analysis supported the authors’ will to continue with the enrollment and to analyze data once the estimated sample size will be reached.
Trial registration: Trial registration number NCT03536130, Registered 24 May 2018 - Retrospectively registered, https://clinicaltrials.gov/ct2/results?cond=&term=NCT03536130&cntry=&state=&city=& dist=