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

NCT07278232 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-19

No results posted yet for this study

Summary

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.

By analyzing the acoustic features of specific vowel sounds using machine learning, we seek to identify voice patterns associated with difficult airways. The ultimate goal is to create a tool that allows for a quick, painless pre-operative risk assessment, enhancing patient safety by better preparing anesthesiologists.
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. 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. 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. 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. Risks and Benefits Benefits: There is no direct medical benefit to participants. The contribution is to future medical knowledge and patient safety.

Risks: The study involves minimal risk. The voice recording is non-invasive and safe. The main risk is the potential loss of confidentiality, which is mitigated by strict data protection protocols.
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

Interventions

OTHER

No Intervention: Observational Cohort

No Intervention

Sponsors & Collaborators

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    lead OTHER

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278232 on ClinicalTrials.gov