Research on a Machine Learning-Based Predictive Model for Difficult Intubation Using Specific Vocal Characteristics

NCT07278232 | Not Yet Recruiting

• 1 other identifier: Difficult Intubation
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Purpose This research aims to develop a novel, non-invasive, and simple method to predict difficult intubation before surgery. The core idea is that the anatomy of a person's throat and mouth, which determines the ease of intubation, also uniquely shapes their voice.
2. 2.Study Design This is a prospective, observational, single-center study. It is purely observational and does not involve any changes to standard medical care or anesthesia procedures.
3. 3.Participants We plan to enroll 300 patients. Who can join: Patients aged 15-70 scheduled for elective surgery requiring general anesthesia with tracheal intubation. Who cannot join: Individuals with speech/hearing impairments, significant neurological diseases affecting speech, or conditions contraindicating standard laryngoscopy.
4. 4.Study Procedures For participants, the study involves one key procedure in addition to standard care:Voice Recording: Before surgery, participants will be asked to lie down and pronounce the vowels "a," "e," and "i" steadily for 1-2 seconds. This will be done twice: once with the head in a normal position and once with the head tilted back. A high-quality recorder will capture the sounds. This process is painless and takes only a few minutes. Standard anesthesia and intubation will then proceed as usual. The anesthesiologist will record the laryngeal view obtained during intubation, which will be used to classify the case as "difficult" or "non-difficult" for analysis.
5. 5.Data Analysis The primary goal is to determine if there are statistically significant differences in the key voice resonance frequencies (F1, F2, F3) between the difficult and non-difficult intubation groups. Advanced machine learning models will be built to create the predictive algorithm.
6. 6.Risks and Benefits Benefits: There is no direct medical benefit to participants. The contribution is to future medical knowledge and patient safety.
7. 7.Confidentiality \& Ethics All patient data will be de-identified and stored securely. The study protocol and informed consent form have been approved by the Institutional Ethics Committee of Shanghai Sixth People's Hospital. Participation is voluntary, and participants may withdraw at any time without affecting their medical care. Written informed consent will be obtained from every participant before any study procedures.

Conditions

Difficult Airway Intubation

Keywords

Difficult Airway Intubation

Outcome Measures

Primary Outcomes (2)

• The corresponding differences in average F1, F2, and F3 between the two sets of speech signals.

  Preoperative Phase

• Differences in F1, F2, and F3 of the same pronunciation before and after changing head position.

  Preoperative Phase

Interventions

No Intervention: Observational Cohort OTHER

No Intervention

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of 15-70 years scheduled for elective general anesthesia with tracheal intubation

You may qualify if:

• Patients scheduled for elective general anesthesia with tracheal intubation.

You may not qualify if:

• Patients with speech and pronunciation disorders (vocal cord diseases, cleft palate, craniofacial deformities, extensive tooth defects, cleft lip).
• Hearing impairment (difficulty in communication, inaccurate repetition).
• Patients with central nervous system diseases causing significant pronunciation abnormalities.
• Patients contraindicated for direct laryngoscopy (e.g., post-chemotherapy in the pharynx, diseases prone to mucosal bleeding, etc.) that affect group allocation, as well as those unable to complete the recording or temporarily reassigned to other anesthesia methods.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Central Study Contacts

Jun Yao

CONTACT

+86 18930173671; guoxinger@126.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 11, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-11

Locations

CN (1)