Endotracheal tubes cleaned with a novel mechanism for secretion removal: A randomized controlled clinical study

INTRODUCTION: Intubation compromises mucus clearance, allowing secretions to accumulate inside the endotracheal tube (ETT). The purpose of this trial was to evaluate a novel device for ETT cleaning. We hypothesized that its routine use would reduce tube occlusion due to mucus accumulation, while decreasing airway bacterial colonization. METHODS: Subjects were randomized to either the use of the device every 8 h, or the institutional standard of care (blind tracheal suction) only. ETTs were collected at extubation and analyzed with high-resolution computed tomography (HRCT) for quantification of mucus volume. Microbiological testing was performed on biofilm samples. Vital signs and ventilatory settings were collected at the bedside. In-hospital follow-up was conducted, and a final evaluation survey was completed by respiratory therapists. RESULTS: Seventy-four subjects expected to remain intubated for longer than 48 h were enrolled (77 ETTs, 37 treatment vs 40 controls). Treated tubes showed reduced mucus accumulation (0.56 ± 0.12 vs 0.71 ± 0.28 mL; P = .004) and reduced occlusion (6.3 ± 1.7 vs 8.9 ± 7.6%; P = .039). The HRCT slice showing the narrowest lumen within each ETT exhibited less occlusion in cleaned tubes (10.6 ± 8.0 vs 17.7 ± 13.4%, 95% CI: 2–12.1; P = .007). Data on microbial colonization showed a trend in the treatment group toward a reduced ETT-based biomass of bacteria known to cause ventilator-associated pneumonia. No adverse events were reported. The staff was satisfied by the overall safety and feasibility of the device. CONCLUSION: The endOclear is a safe and effective device. It prevents luminal occlusion, thereby better preserving ETT nominal function.