Validation of End-to-End Difficult Airway Pathway Planning Algorithm (EAP-LC)
70 participantsStarted 2026-01-01
Plain-language summary
Patients with laryngeal cancer often present with varying degrees of airway narrowing or anatomical distortion, making airway management particularly challenging. Awake flexible bronchoscopic intubation is a widely accepted and important strategy to ensure airway safety in this population. Currently, the selection of the intubation pathway mainly relies on visual assessment of preoperative computed tomography (CT) images and the clinical experience of anesthesiologists, lacking objective and quantifiable tools for airway pathway planning.
Our research group has developed an end-to-end airway pathway planning algorithm for laryngeal cancer patients (EAP-LC), which can automatically generate predicted nasal or oral intubation pathways based on preoperative pharyngeal and upper airway CT images. Preliminary simulation analyses based on retrospective CT data demonstrated that the algorithm is capable of identifying airway narrowing and generating trajectories that are close to clinically feasible intubation paths (preliminary data, under review). However, to date, no study has directly compared the algorithm-predicted pathways with actual intubation trajectories obtained during awake flexible bronchoscopic intubation. Therefore, a prospective clinical validation study is required to evaluate the spatial consistency and clinical feasibility of the EAP-LC algorithm.
Without altering routine clinical treatment or anesthetic management, this study aims to evaluate the clinical accuracy, safety, and feasibility of the EAP-LC algorithm by comparing the intubation pathways predicted from preoperative CT images with the real-world trajectories recorded during awake flexible bronchoscopic intubation. The results of this study are expected to provide a more precise and objective decision-support tool for airway management in patients with laryngeal cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
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Inclusion Criteria:
* Patients scheduled to undergo laryngeal cancer surgery under general anesthesia, including supraglottic, glottic, and subglottic laryngeal cancers, as well as lesions involving the hypopharynx-larynx junction, who are assessed preoperatively as requiring awake flexible bronchoscopic intubation. Eligible participants must meet all of the following criteria: age ≥ 18 years, with no restriction on sex; a confirmed diagnosis of laryngeal cancer or laryngeal tumor based on previous or preoperative imaging and/or pathological findings; a planned laryngeal surgical procedure; a preoperative anesthetic assessment indicating the need for awake flexible bronchoscopic intubation to ensure airway safety; completion of contrast-enhanced laryngeal and/or cervical computed tomography (CT) within 2 weeks prior to surgery, with image quality adequate for analysis by the EAP-LC algorithm; clear consciousness, the ability to understand the study procedures, and voluntary provision of written informed consent.
Exclusion Criteria:
* Patients will be excluded if they meet any of the following conditions: inability to cooperate with awake intubation due to severe anxiety, cognitive impairment, or psychiatric disorders; a history of total laryngectomy or loss of normal laryngeal anatomical structures that precludes oral or nasal flexible bronchoscopic intubation; severe coagulation disorders or an uncontrollable risk of bleeding; or any other condition deemed by the investig…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
proportion of cases
Timeframe: During the awake flexible bronchoscopic intubation procedure