Abstract
BACKGROUND: Poor oral hygiene in patients with tracheal intubation will increase the occurrence of dental plaque and mucosal inflammation, resulting in oral barrier dysfunction. This study aimed to design and evaluate a novel double-lumen endotracheal tube (DETT) and explore its role in infection control, particularly its effects on the oral microenvironment and ventilator-associated pneumonia (VAP). METHODS: This was a prospective, non-blinded, randomized parallel-controlled trial conducted from July 2024 to September 2024. A total of 115 patients who had been intubated for more than 3 days in a tertiary hospital ICU were enrolled and randomly assigned to either the DETT group (n = 58) or the conventional endotracheal tube (ETT) group (n = 57). Both groups received the same oral care protocols. The DETT group was intubated with the double-lumen endotracheal tube, which included a built-in bite block, while the ETT group used a standard endotracheal tube with a bite block. The primary outcome was the incidence of VAP, while secondary outcomes included oral bacterial colony counts, biofilm formation, BOAS oral health scores, and plaque index. RESULTS: Compared to the ETT group, the DETT group showed a significant reduction in VAP incidence (χ²=4.382, p < 0.05). The DETT group also had significantly lower oral bacterial colony counts (Z=-7.362, P < 0.05) and biofilm formation (χ²=5.472, p < 0.05), as well as better BOAS scores (Z=-2.774, p < 0.05). However, there were no significant differences between the two groups in pathogenic bacterial presence or plaque index (p > 0.05). CONCLUSIONS: The novel double-lumen endotracheal tube effectively reduces the total bacterial load in the oral cavity, inhibits biofilm formation, and lowers the incidence of VAP. It also improves oral function and hygiene, contributing to infection control, and holds significant clinical value.