Abstract
Endotracheal intubation is a crucial intervention for mechanically ventilated patients in the intensive care unit (ICU). However, the presence of the tube and bite block in the mouth significantly raises the risk of mucosal pressure injuries (MMPI) and other oral complications. These complications not only compromise oral health but also prolong hospitalisation and increase medical costs. Despite advances in airway management, effective solutions to mitigate these risks remain limited. Few studies have explored reducing mucosal pressure and improving oral health by optimising the design and reducing the volume of oral devices. Therefore, this study aimed to design and evaluate a novel nested tracheal tube device to reduce oral MMPI and improve oral health outcomes in intubated patients. A prospective, non-blinded, randomised, parallel-controlled intervention study was conducted, involving 151 patients who were intubated for more than 48 h. Participants were randomly assigned into two groups: the intervention group (n = 75), which received the novel nested tracheal tube device, and the control group (n = 76), which received the standard endotracheal tube with bite block. The primary outcome measure was the incidence of MMPI. Secondary outcomes included the Beck Oral Health Score, plaque index, ventilator-associated pneumonia (VAP) and costs. Compared to the standard group, the nested tracheal tube group showed a significant reduction in MMPI (χ(2) = 8.796, p < 0.05). In addition, the nested tracheal tube group demonstrated significantly better outcomes in Beck Oral Health Scores (Z = -2.948, p < 0.05) and plaque index (Z = -2.010, p < 0.05), indicating improvements in oral function and hygiene. However, there were no significant differences between the two groups in VAP incidence and average daily ICU costs (p > 0.05). The nested tracheal tube effectively reduces localised pressure on oral tissues and improves oral function, offering a practical solution to mitigate MMPI in mechanically ventilated patients and enhance their oral health outcomes.