- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411495
To Create an Artificial Intelligence-enabled Device for Airway Assessment (AINFAS) to Identify Patients With Difficult Airway Pre-operatively.
February 8, 2026 updated by: National University Hospital, Singapore
Artificial INtelligence eNabled 3D Facial Scanner for Airway Assessment (AINFAS)
We're developing a new AI, which uses advanced computer technology to help doctors identify patients who might have a difficult airway before surgery or emergency procedures.
Sometimes, when a person needs help breathing, doctors have to insert a tube into their airway.
This can be challenging for some people due to the shape of their mouth, throat, or neck.
We hope that AI will look at a patient's facial features to predict if there might be any difficulties.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
AINFAS (Artificial Intelligence-enabled system for airway assessment) is an innovative AI system we're developing to revolutionize airway management in healthcare.
This advanced artificial intelligence is designed to analyze patient characteristics and predict potential difficulties in airway management before any medical procedure that might require breathing assistance.
Using sophisticated machine learning algorithms, AINFAS processes data such as facial structure and neck anatomy to assess the likelihood of a difficult airway.
This non-invasive, rapid assessment tool has potential applications across various healthcare settings, including pre-operative assessments, emergency departments, intensive care units, and even pre-hospital care.
By providing early identification of potential airway challenges, AINFAS aims to enhance patient safety, improve resource allocation, and provide a standardized, objective method of airway assessment.
Currently in development and testing, this AI system represents a significant step forward in using technology to enhance clinical decision-making and patient safety in critical aspects of medical care.
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 119074
- National University Hospital Singapore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients that undergoing surgery in National University Hospital Singapore Only.
Description
Inclusion Criteria:
- Undergoing surgery under general anaesthesia requiring endotracheal intubation or supraglottic airway
- 21-100 years old
Exclusion Criteria:
- Age less than 21 years
- Patients with prior surgery with altered facial appearance
- Patients with tracheostomy
- Patients with any oropharyngeal pathology
- Patients with nasopharyngeal carcinoma post radiotherapy or chemotherapy
- Pregnant females
- Patients whose physicians did not use a laryngoscope or supraglottic airway
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General anaesthesia surgery
|
participants having their photograph taken using a tablet device following a standardized protocol to capture relevant facial and neck features.
These photographs will then be analyzed using software, which assesses the images for potential indicators of a difficult airway.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of AINFAS in Predicting Difficult Airways
Time Frame: Assessment will occur from the time of preoperative AI analysis through to the completion of the intubation procedure, typically within 48 hours.
|
To identify and characterize the key predictive parameters that contribute to the AI system's overall ability to detect difficult airways.
|
Assessment will occur from the time of preoperative AI analysis through to the completion of the intubation procedure, typically within 48 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of Novel Predictors of Difficult Airways
Time Frame: Data analysis will be conducted after completion of all participant procedures, typically within 2 years of the last participant's assessment.
|
To identify and characterize new predictive parameters that contribute to the AI system's overall ability to determine the likelihood of a difficult airway.
|
Data analysis will be conducted after completion of all participant procedures, typically within 2 years of the last participant's assessment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Will Ne-Hooi Loh, National University Hospital, Singapore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2022
Primary Completion (Actual)
January 24, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 21, 2025
First Submitted That Met QC Criteria
February 8, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 8, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021/00908
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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