Assessing Infant ETT Securement Methods in Simulation: Study Protocol

Abstract

Study objective Secure fixation of the endotracheal tube in infants is essential to prevent unintentional dislodgement in prehospital and in-hospital emergency care. This prospective, comparative experimental multicenter simulation study is designed to evaluate different tube fixation methods in an infant airway manikin with respect to maximum force required to induce dislodgement, time to secure fixation, and user-perceived practicality.

Methods Participants from various professional backgrounds with differing levels of airway management experience (total n = 60) will secure endotracheal tubes to a standardized infant airway manikin across multiple study rounds. Two established fixation methods  – gauze bandage (roll), the Lillehei method (Leukoplast® brown) – will be compared with a novel fixation method: Peha-Haft® (roll), with random allocation of the fixation method.
The primary outcome will be the maximum force required to cause tube dislodgement. Extubation force will be measured using a calibrated digital force gauge attached to a predefined device at a standardized traction angle. Secondary outcomes include time to achieve secure fixation and user-perceived usability, assessed using a structured questionnaire.
Data analysis will be performed using descriptive statistics and analysis of variance (ANOVA) to assess differences between fixation methods. Planned subgroup analyses will explore the influence of professional qualification level and organizational background.

Discussion Data collection is ongoing, and no preliminary results are available as of the abstract submission deadline. The study seeks to identify the optimal infant endotracheal tube fixation strategy in a controlled simulation setting with regard to dislodgement resistance, usability, and time efficiency. Although the use of a manikin model may limit external validity, the findings may inform evidence-based pediatric emergency airway management recommendations.