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Background <p>Endotracheal intubation is a high-stakes intervention in emergency airway management, with patient safety closely linked to first-pass success and avoidance of repeated attempts. The Frankfurt Intubation Device (FID) is a bougie-inspired intubation device intended to provide fast protection against aspiration once positioned in the trachea.</p> Methods <p>This dual-center randomized crossover simulation study used an easy-to-intubate airway manikin. Ninety participants were divided into three groups of different experience (anesthesiologists, non-physician critical care staff, and medical students) to perform intubation with the Frankfurt Intubation Device (FID) and a standard endotracheal tube with stylet in randomized order. The primary outcome was non-inferiority of time to airway protection, measured from laryngoscope insertion to inflation of a cuffed device positioned in the trachea (T2; Δ = 5&#xa0;s). Secondary outcomes included first-pass success, tooth damage, and exploratory assessment of training effects, with additional time-based outcomes assessed descriptively.</p> Results <p>Across all participants, the FID was non-inferior to the endotracheal tube with stylet for T2 (mean paired difference − 0.77&#xa0;s, 95% CI − 2.50 to 0.97; non-inferiority margin 5&#xa0;s). Exploratory analyses demonstrated consistent non-inferiority for T2 across experience groups (G1–G3) and randomization sequences. First-pass success was high in both arms (FID 96.7% vs. ET+stylet 94.4%), while tooth damage occurred less frequently with the FID (7.8% vs. 14.4%). Training effects were observed in the simulator.</p> Conclusion <p>In this standardized simulation study using an easy-to-intubate airway manikin, the Frankfurt Intubation Device demonstrated non-inferiority to conventional endotracheal intubation with stylet for time to airway protection. Secondary findings support continued staged evaluation of the FID, particularly in more challenging airway scenarios and among users with limited airway experience, where differences in procedural performance may become more apparent.</p> Trial registration <p>Not applicable (simulation study).</p>

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Time to intubate with an innovative intubation device: a dual-center randomized crossover non-inferiority simulation study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月11日

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  • Hans Magnus Haveraaen,
  • Udo Seel,
  • Broder Romeike,
  • Sebastian Zinn,
  • Haitham Mutlak,
  • Kai Zacharowski,
  • Vanessa Neef,
  • Benjamin Friedrichson,
  • Jan Andreas Kloka

摘要

Background

Endotracheal intubation is a high-stakes intervention in emergency airway management, with patient safety closely linked to first-pass success and avoidance of repeated attempts. The Frankfurt Intubation Device (FID) is a bougie-inspired intubation device intended to provide fast protection against aspiration once positioned in the trachea.

Methods

This dual-center randomized crossover simulation study used an easy-to-intubate airway manikin. Ninety participants were divided into three groups of different experience (anesthesiologists, non-physician critical care staff, and medical students) to perform intubation with the Frankfurt Intubation Device (FID) and a standard endotracheal tube with stylet in randomized order. The primary outcome was non-inferiority of time to airway protection, measured from laryngoscope insertion to inflation of a cuffed device positioned in the trachea (T2; Δ = 5 s). Secondary outcomes included first-pass success, tooth damage, and exploratory assessment of training effects, with additional time-based outcomes assessed descriptively.

Results

Across all participants, the FID was non-inferior to the endotracheal tube with stylet for T2 (mean paired difference − 0.77 s, 95% CI − 2.50 to 0.97; non-inferiority margin 5 s). Exploratory analyses demonstrated consistent non-inferiority for T2 across experience groups (G1–G3) and randomization sequences. First-pass success was high in both arms (FID 96.7% vs. ET+stylet 94.4%), while tooth damage occurred less frequently with the FID (7.8% vs. 14.4%). Training effects were observed in the simulator.

Conclusion

In this standardized simulation study using an easy-to-intubate airway manikin, the Frankfurt Intubation Device demonstrated non-inferiority to conventional endotracheal intubation with stylet for time to airway protection. Secondary findings support continued staged evaluation of the FID, particularly in more challenging airway scenarios and among users with limited airway experience, where differences in procedural performance may become more apparent.

Trial registration

Not applicable (simulation study).