A new randomized controlled trial has demonstrated that the AMT Bridle Pro® nasal bridle system significantly reduces feeding tube dislodgement in hospitalized children compared to conventional tape methods, potentially improving nutritional outcomes and reducing healthcare resource utilization.
The study, conducted at a tertiary pediatric hospital in South Texas between February 2020 and January 2021, found that feeding tubes secured with the nasal bridle were nearly three times less likely to dislodge than those secured with traditional adhesive tape.
Significant Reduction in Tube Dislodgement
Researchers randomized 35 pediatric patients requiring nasoenteric feeding tubes to either the AMT Bridle Pro® group (n=17) or conventional tape group (n=18). The results were striking: within 30 days, 88.2% of tape-secured tubes dislodged compared to only 31.3% of bridle-secured tubes.
"The primary analysis revealed the rate of feeding tube dislodgement was significantly higher in the tape group compared to the bridle group, with an attributable risk reduction of 57% and number needed to treat of 1.75," the researchers reported.
Statistical analysis showed a hazard ratio of 6.3 (95% CI 2.38–16.5, p<0.0001), indicating that tape-secured tubes were more than six times more likely to dislodge than bridle-secured tubes at any given time during the study period.
Mechanism and Safety Profile
The AMT Bridle Pro® works by placing a thin plastic anchor around the vomer bone in the nasal cavity, providing a more secure attachment point than adhesive tape on the skin. The device is designed with a safety feature that allows the feeding tube to slip through if excessive tension is applied, preventing damage to the nasal septum.
Of the five unintentional tube dislodgements in the bridle group, two occurred when the tube slipped through the bridle as designed (with the bridle remaining in place), while three occurred when patients vomited the tube out through the mouth.
Safety data was encouraging, with no serious adverse events reported. One patient was withdrawn from the bridle group due to erythema on the nasal septum, which resolved quickly after removal. In contrast, four patients in the tape group developed erythema and skin breakdown where the tape was secured.
Clinical Implications
Nasoenteric feeding tubes are essential for delivering nutrition and medication to hospitalized children who cannot tolerate oral intake. Traditional adhesive tape methods fail to prevent dislodgement in approximately 40% of cases, leading to interrupted nutrition, increased radiation exposure from confirmation X-rays, and additional healthcare costs.
"Consistent delivery of nutrition results in positive nutritional outcomes as well as maintaining the integrity of intestinal mucosa, reducing bacterial translocation, and decreasing infectious complications," the researchers noted.
The study also found that patients with bridle-secured tubes required fewer confirmation X-rays (31% vs. 76% in the tape group), suggesting potential resource savings.
Benefits for Trauma Patients
The researchers highlighted particular benefits for trauma patients, especially those with facial burns. As a Level 1 Pediatric Trauma Center, the study site treated several patients with severe facial burns, comprising approximately 29% of the study population.
"The trauma care team noted to the investigators that use of the bridle in these patients prevented dislodgement and the material of the bridle was easier to clean than adhesive tape," the authors reported.
Study Limitations
The researchers acknowledged several limitations, including the lack of standardization in tape securement methods, variety in feeding tube types used, and early termination of the study due to the significant difference observed between groups and staffing challenges during the COVID-19 pandemic.
Despite these limitations, the findings align with previous retrospective studies in pediatric populations that have shown reduced dislodgement rates, fewer emergency department visits, and shorter hospital stays with bridled feeding tubes.
Future Directions
The researchers plan to expand bridle use throughout their hospital and increase staff comfort with the technology. Long-term goals include extending bridle use to outpatient settings, potentially allowing patients to be discharged home with bridled nasoenteric feeding tubes.
"This may lead to fewer invasive gastrostomy tube procedures and improve family satisfaction with care," the authors concluded.
The AMT Bridle Pro® is FDA-cleared for up to 30 days of continuous use, though some studies have reported safe use for 2-3 months. The device is available in various sizes suitable for both pediatric and adult patients.
