Automated Assessment of Difficult Airway With Facial Recognition Techniques (PeScho)

May 7, 2024 updated by: Patrick Schoettker, University of Lausanne Hospitals

Automatic Assessment of Difficult Ventilation and Intubation From Automatic Face Analysis and Artificial Intelligence

General anaesthesia mandates artificial ventilation and tracheal intubation in order to provide patients with artificial breathing. Difficulties related to ventilation and intubation remain the leading cause of morbidity and mortality in general anaesthesia, essentially due to inaccuracies in pre-operative detection of anatomical factors predisposing to difficult airways. In this project investigators will develop image and video-processing technologies software solutions to allow automatic recognition of anatomical features playing a key role in identification of difficult ventilation and intubation, leading to modifications in pre-operative anaesthesia management assessment and therefore increase patients' safety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Any tracheal intubation requires a pre-operative screening and assessment in order to obtain the essential medical history of the patient, optimize patients' condition in case of any co-existing disease before the operation and select the best method of anesthesia for the day of surgery. The aim of this assessment is to identify potential anesthetic difficulties, such as predictors of difficult airways, which still nowadays represent the first cause of litigation in anesthesia related closed claim studies.

In the first step of the pre-operative assessment procedure, the patient will be analyzed by the software. The patient will be automatically guided through a 10 minutes series of tests and the software will analyze in real-time his/her morphological and dynamic features in order to classify the patient into one of 5 categories described in the next Section. Details relevant to difficult ventilation and intubation (static and dynamic), such as quantifying the exact inter-incisors distance (mouth opening), visibility and detection of anatomical landmarks in the open mouth (uvulae, pillars, tonsils, tongue, posterior pharynx), thyro-mental distance, neck circumference, neck mobility with maximal anterior and posterior movement. The analysis will be performed by:

  • automatically computing these relevant measures using robust computer vision algorithms capable to detect, describe and track the face and the neck with high level of accuracy and robustness to extreme poses (left and right rotation and up and down movement of the face)
  • developing powerful image processing techniques to describe and compute intra-oral structures. The two sets of measures will be then combined into a machine learning approach capable to classify the patient. The results of the analysis as well as all the recorded videos of every single test will be stored on a central database and accessed in real-time by the doctor to continue the pre-operative consultancy.

The patient will then undergo his planned surgery at the initially planned time and be intubated for that purpose. Proper recording of the grade of intubation in the operating room will be documented and introduced in the assessment database. By this mean, the database will evolve with the assessment and the final post-operative intubation score so that to improve the automatic predictability of the machine learning algorithm.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Recruiting
        • Dpt of Anesthesiology, University of Lausanne CHUV
        • Contact:
        • Principal Investigator:
          • Patrick Schoettker, Assoc Prof

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patient undergoing general anesthesia necessitating endotracheal intubation

Description

Inclusion Criteria:

  • adult patient (15 years of age)
  • patients necessitating endotracheal intubation for general anesthesia

Exclusion Criteria:

-patient refusal

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
difficult intubation
general population necessitating tracheal intubation for general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Computerized classification of difficult intubation
Time Frame: 1 day
automatic classification by artificial intelligence into 3 classes of intubation difficulty
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lausanne Hospitals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ecole Polytechnique Fédérale de Lausanne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Schoettker, Assoc Prof, University of Lausanne Hospitals

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 183/09
  • CTI (Other Grant/Funding Number: Swiss Commission Technology and Innovation 12636.1)

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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