A learning curve of a novel multimodal endotracheal intubation assistant device for novices in a simulated airway: a prospective manikin trial with cumulative sum method

Background: Awake fiberoptic intubation is conventionally performed in anticipated difficult airways. However, obstruction by secretions and sputum makes it challenging for novices. A prototype of a novel multimodal endotracheal intubation assistant device (MEIAD) was developed for an indication of airway according to end-tidal carbon dioxide (ETCO₂) and image. At the tip, 4 sampling tubes collected ETCO₂ concentration. The airway direction is located according to an advanced algorithm based on 4 directions' concentrations. It assists awake intubation, especially with unclear view field. The objective was to analyze the learning curve of MEIAD for novices on a manikin by cumulative sum method (CUSUM) and evaluate the utility.

Methods: A total of 16 novice residents with less than 2-year clinical experience were enrolled. After instruction, each individual exercised 40 insertions with MEIAD on a difficult airway simulation. Insertion success (defined as a visualization of the carina within 120 seconds), insertion time (the time from when the guiding scope entered the nasal cavity to the carina was visible), and self-confidence score (subjective score with a numerical rating scale from 0 to 10) were recorded. The acceptable and unacceptable failure rates of CUSUM were set as 15% and 30%, respectively. The exercises were divided into 2 phases (phase 1: 1-20, phase 2: 21-40) for further evaluation. All continuous data were expressed by median (IQR, interquartile ranges) and analyzed using Mann-Whitney test. All categorical variables were expressed as percentages and compared by the χ² test.

Results: Among the 16 residents, 15 were able to cross the lower decision boundary in an average of 21.27±9.51 attempts using the novel device. The insertion time [24.0 (17.0-42.0) vs. 17.5 (14.0-28.0) seconds, P<0.001] and success rate (88.4% vs. 97.5%, P<0.001) were improved with increased experience. The confidence score was significantly improved from 2.5 (1.3-4.0) to 7.0 (7.0-8.0).

Conclusions: MEIAD showed a satisfactory learning curve and efficacy on the manikin for novices. However, as a small exploratory manikin trial, the results cannot be replicated in clinical practice. MEIAD is expected to be further improved and potential to be an alternative device for difficult airways.