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Active, Not Recruiting

NCT Number: NCT07411495

To Create an Artificial Intelligence-enabled Device for Airway Assessment (AINFAS) to Identify Patients With Difficult Airway Pre-operatively.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anaesthesia

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital Singapore

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-Assisted Preoperative Airway Risk Assessment

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National University of Singapore

Registry information

Official study title

Artificial INtelligence eNabled 3D Facial Scanner for Airway Assessment (AINFAS)

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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