Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis

Federico Rea,Sara Pieropan,Camillo Lopez,Luigi Gaetano Andriolo,Giovanni Maria Comacchio,Mario Nosotti,Gianluca Bonitta,Davide Tosi,Giovanna Imbriglio,Debora Brascia,Giuseppe Marulli,Paolo Mendogni,Veronica Rossi

doi:10.1186/s13019-021-01567-y

Abstract

BackgroundThe 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.MethodsAn 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.ResultsFrom April 2017 to November 2018, out of 317 patients 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.ConclusionsThis interim analysis supported the authors’ will to continue with the enrollment and to analyze data once the estimated sample size will be reached.Trial registrationTrial registration number NCT03536130, Registered 24 May 2018 - Retrospectively registered.

Highlights

The usefulness of digital chest drain is still debated
Air leaks are common after pulmonary resection, affecting patients with a prevalence ranging from 3 to 33%, and are associated with increased morbidity, prolonged hospital stay and increased costs [1, 2]
The interim main endpoint was overall complications within 30 days of the surgery; secondary endpoints were the concordance between the two primary endpoints of the randomized controlled trials (RCT)

Summary

Introduction

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. Digital drainages provide a continuous and objective assessment of air leaks, minimizing interobserver variability [3], reducing the need for tube clamping trials and optimizing the timing of chest tube removal. These modern systems could be able to distinguish an active air leak from pleural space effect by evaluating the differential intrapleural pressure [4]. Digital devices could help identify patients at high risk for prolonged air leak, allowing a better patient management in terms of either active intervention or early discharge from the hospital with a one-way valve system [5, 6]

Methods

Results

Conclusion