Difficult AirwayNCT06626204
Exploration and Application of Intelligent Difficult Airway Assessment Scheme
An observational study of Difficult Airway, run by Min Su at 1 site in China.
Trial summary
The study aims to explore the effectiveness of an intelligent difficult airway assessment protocol and its potential in clinical applications. The management of difficult airways is a critical task in anesthesiology, and poor management can lead to severe complications or even death. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- How many people
- 475 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2024to 10 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective general anesthesia with endotracheal intubation.
Who may be able to join
- Age ≥18 years, with no gender restrictions;
- Subjects who are scheduled to undergo elective general anesthesia and require endotracheal intubation;
- Subjects classified as American Society of Anesthesiologists Physical Status (ASA-PS) Class I, II, and III;
- Volunteers who are willing to participate in this clinical trial and have signed the Informed Consent Form.
Who cannot join
- Subjects with known airway deformities, tumors, or other structural abnormalities that may affect airway assessment;
- Subjects with psychiatric disorders or other conditions that prevent cooperation;
- Pregnant or lactating women;
- Subjects who have participated in other interventional clinical trials within 1 month prior to the start of this trial;
- Subjects deemed inappropriate to participate in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
The study aims to explore the effectiveness of an intelligent difficult airway assessment protocol and its potential in clinical applications. The management of difficult airways is a critical task in anesthesiology, and poor management can lead to severe complications or even death. The American Society of Anesthesiologists defines a difficult airway as one that presents difficulties in mask ventilation or endotracheal intubation. Previous studies have shown that the incidence of difficult airways is not low in patients undergoing general anesthesia, emphasizing the need for optimization of airway management strategies.
Preoperative airway assessment is an essential step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are two commonly used assessment tools. However, these methods rely on the subjective judgment of clinicians and may have limitations in accuracy and consistency. With the development of artificial intelligence and telemedicine technologies, new assessment methods have become possible, offering more precise measurements and analysis of airway anatomy.
Read more
This study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways.
As a country with a large population, China has a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China's population may affect airway structure, thereby influencing airway management strategies. Therefore, conducting such research in China has important clinical significance and social value.
Read the detailed description
The research background is based on a critical issue in anesthetic practice - the management of difficult airways. A difficult airway refers to the challenges encountered during mask ventilation or endotracheal intubation, which can lead to severe complications or even death. The American Society of Anesthesiologists (ASA) defines a difficult airway as one that presents difficulties in mask ventilation, laryngoscopy, use of supraglottic airway devices, endotracheal intubation, extubation, or invasive airway access, including but not limited to situations that are anticipated or unanticipated. Studies have shown that the incidence of difficult and unventilatable mask airways in the general subject population is 2.2% and 0.15%, respectively, while the rate of difficult or failed intubation in general anesthesia events is between 0.43% and 0.52%. These data highlight the importance of accurate airway assessment before anesthesia.
In China, due to the large population, there is a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China's population, including regional, ethnic, and genetic background differences, may affect airway structure, thereby influencing airway management strategies. Therefore, conducting research on the assessment and management of difficult airways in China has important clinical and social significance.
Preoperative airway assessment is a key step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are commonly used assessment tools in clinical practice. The modified Mallampati classification assesses the difficulty of the airway by observing the visibility of structures within the oral cavity, while the Cormack-Lehane grading assesses it through the visibility of laryngeal structures during direct laryngoscopy. Although these methods are widely used in clinical practice, they have issues with subjectivity, poor repeatability, and limited accuracy.
With the advancement of medical technology, especially the rapid development of artificial intelligence (AI) and telemedicine, new opportunities have emerged to improve the assessment methods for difficult airways. The use of intelligent devices and algorithms can provide more precise measurements and analysis of the subject's airway anatomy, thereby improving the accuracy and reliability of the assessment. This new method not only reduces the interference of subjectivity but also improves the repeatability of the assessment through standardized image collection and analysis processes.
This study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways.
The clinical significance of the study lies in the fact that, with more accurate airway assessment, anesthesiologists can take appropriate preventive measures and strategies in advance, reducing complications due to improper airway management, such as hypoxia, failed intubation, etc. This will directly improve surgical safety, reduce the postoperative recovery time and medical costs for subjects. In addition, the results of the study may also provide new theoretical bases and practical guidelines for the field of airway assessment, promoting the development and innovation of related technologies and methods.
The social value of conducting such research in China is that, with the trend of digital transformation in the medical industry, the application of intelligent airway assessment methods helps to improve overall medical efficiency and subject safety. In areas with limited resources or remote geographical locations, doctors can use remote connections and intelligent devices to assess the airways of subjects, achieving high-quality medical services.
- Conditions
- Difficult Airway
- Keywords
- Difficult Airway, artificial intelligence, Modified Mallampati Classification
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between intelligent airway assessment and modification of Mallampati classification and Cormack-Lehane grading.
Measured: From enrollment to one day after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start23 Sep 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Min Su, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626204
- Sponsor's protocol ID
- 202409701
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration and Application of Intelligent Difficult Airway Assessment Scheme
- ClinicalTrials.gov ID
- NCT06626204
- Acronym / sponsor ID
- 202409701
- Conditions
- Difficult Airway
- Keywords
- Difficult Airway, artificial intelligence, Modified Mallampati Classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore the effectiveness of an intelligent difficult airway assessment protocol and its potential in clinical applications. The management of difficult airways is a critical task in anesthesiology, and poor management can lead to severe complications or even death. The American Society of Anesthesiologists defines a difficult airway as one that presents difficulties in mask ventilation or endotracheal intubation. Previous studies have shown that the incidence of difficult airways is not low in patients undergoing general anesthesia, emphasizing the need for optimization of airway management strategies.
Preoperative airway assessment is an essential step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are two commonly used assessment tools. However, these methods rely on the subjective judgment of clinicians and may have limitations in accuracy and consistency. With the development of artificial intelligence and telemedicine technologies, new assessment methods have become possible, offering more precise measurements and analysis of airway anatomy.
This study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways.
As a country with a large population, China has a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China's population may affect airway structure, thereby influencing airway management strategies. Therefore, conducting such research in China has important clinical significance and social value.
Detailed description
The research background is based on a critical issue in anesthetic practice - the management of difficult airways. A difficult airway refers to the challenges encountered during mask ventilation or endotracheal intubation, which can lead to severe complications or even death. The American Society of Anesthesiologists (ASA) defines a difficult airway as one that presents difficulties in mask ventilation, laryngoscopy, use of supraglottic airway devices, endotracheal intubation, extubation, or invasive airway access, including but not limited to situations that are anticipated or unanticipated. Studies have shown that the incidence of difficult and unventilatable mask airways in the general subject population is 2.2% and 0.15%, respectively, while the rate of difficult or failed intubation in general anesthesia events is between 0.43% and 0.52%. These data highlight the importance of accurate airway assessment before anesthesia.
In China, due to the large population, there is a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China's population, including regional, ethnic, and genetic background differences, may affect airway structure, thereby influencing airway management strategies. Therefore, conducting research on the assessment and management of difficult airways in China has important clinical and social significance.
Preoperative airway assessment is a key step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are commonly used assessment tools in clinical practice. The modified Mallampati classification assesses the difficulty of the airway by observing the visibility of structures within the oral cavity, while the Cormack-Lehane grading assesses it through the visibility of laryngeal structures during direct laryngoscopy. Although these methods are widely used in clinical practice, they have issues with subjectivity, poor repeatability, and limited accuracy.
With the advancement of medical technology, especially the rapid development of artificial intelligence (AI) and telemedicine, new opportunities have emerged to improve the assessment methods for difficult airways. The use of intelligent devices and algorithms can provide more precise measurements and analysis of the subject's airway anatomy, thereby improving the accuracy and reliability of the assessment. This new method not only reduces the interference of subjectivity but also improves the repeatability of the assessment through standardized image collection and analysis processes.
This study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways.
The clinical significance of the study lies in the fact that, with more accurate airway assessment, anesthesiologists can take appropriate preventive measures and strategies in advance, reducing complications due to improper airway management, such as hypoxia, failed intubation, etc. This will directly improve surgical safety, reduce the postoperative recovery time and medical costs for subjects. In addition, the results of the study may also provide new theoretical bases and practical guidelines for the field of airway assessment, promoting the development and innovation of related technologies and methods.
The social value of conducting such research in China is that, with the trend of digital transformation in the medical industry, the application of intelligent airway assessment methods helps to improve overall medical efficiency and subject safety. In areas with limited resources or remote geographical locations, doctors can use remote connections and intelligent devices to assess the airways of subjects, achieving high-quality medical services.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective general anesthesia with endotracheal intubation.
Key inclusion criteria (4 listed)
- Age ≥18 years, with no gender restrictions;
- Subjects who are scheduled to undergo elective general anesthesia and require endotracheal intubation;
- Subjects classified as American Society of Anesthesiologists Physical Status (ASA-PS) Class I, II, and III;
- Volunteers who are willing to participate in this clinical trial and have signed the Informed Consent Form.
Key exclusion criteria (5 listed)
- Subjects with known airway deformities, tumors, or other structural abnormalities that may affect airway assessment;
- Subjects with psychiatric disorders or other conditions that prevent cooperation;
- Pregnant or lactating women;
- Subjects who have participated in other interventional clinical trials within 1 month prior to the start of this trial;
- Subjects deemed inappropriate to participate in this clinical trial by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between intelligent airway assessment and modification of Mallampati classification and Cormack-Lehane grading.
Time frame: From enrollment to one day after extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Su study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway, run by Min Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between intelligent airway assessment and modification of Mallampati classification and Cormack-Lehane grading. (time frame: From enrollment to one day after extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.