Validation of End-to-End Difficult Airway Pathway Planning Algorithm (EAP-LC)

NCT ID: NCT07324317

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Laryngeal Cancer; Difficult Airway

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Awake Flexible Bronchoscopic Intubation Group

No Interventions

Intervention Type: OTHER

No Intervention

Interventions

No Interventions

No Intervention

Intervention Type: OTHER

Eligibility Criteria

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 investigators to make participation inappropriate, such as refusal of video recording or special confidentiality requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xia Shen

Role: CONTACT

shenxiash@fudan.edu.cn

+862164377134

References

1. McTigue C, McGoldrick KE，Airway management in head and neck cancer: A review. Curr Opin Anaesthesiol. 2021;34(1):41-49. 2. Awake fiberoptic intubation in the management of the difficult airway. Anesth Analg. 2001;92(6):1523-1528. 3. Awake tracheal intubation: a modern, high-value technique in airway management.Br J Anaesth. 2023;130(2):e151-e154. 4. Cook TM, Woodall N, Frerk C, et al. Major complications of airway management in the United Kingdom: results of the 4th National Audit Project (NAP4). Br J Anaesth. 2011;106(5):617-631. 5. Ozgul G, Cetinkaya E, Ozgul MA, et al. Efficacy and safety of electromagnetic navigation bronchoscopy with or without radial endobronchial ultrasound for peripheral lung lesions. Endosc Ultrasound. 2016;5:189-195. 6. Ahmad I, El-Boghdadly K, Bhagrath R, et al. Difficult Airway Society guidelines for awake tracheal intubation (ATI) in adults. Anaesthesia. 2020;75(4):509-528. 7. Rosenstock CV, Thøgersen B, Afshari A, Christensen AL, Eriksen C, Gätke MR. Awake fiberoptic or awake video laryngoscopic tracheal intubation in patients with anticipated difficult airway management: a randomized clinical trial. Anesthesiology. 2012;116(6):1210-1216. 8. Kramer A, Muller D, Pfannenstiel C, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC D-BLADE) nasal awake intubation in head and neck cancer patients with difficult airways - a randomized clinical trial.Anaesthesia. 2015;70(12):1311-1316. 9. Mendonca C, Mesbah A, Velayudhan A, Danha R. A randomized clinical trial comparing the flexible fibrescope and the Pentax Airway Scope® for awake oral tracheal intubation. Anaesthesia. 2016;71(8):908-914.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2025321

Identifier Type: -

Identifier Source: org_study_id