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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02022397
Other study ID # 183/09
Secondary ID CTI
Status Recruiting
Phase
First received
Last updated
Start date March 2012
Est. completion date December 23, 2024

Study information

Verified date May 2024
Source University of Lausanne Hospitals
Contact Patrick Schoettker, Assoc Prof
Phone +41795561043
Email patrick.schoettker@chuv.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date December 23, 2024
Est. primary completion date December 23, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - adult patient (15 years of age) - patients necessitating endotracheal intubation for general anesthesia Exclusion Criteria: -patient refusal

Study Design


Related Conditions & MeSH terms

  • Adverse Effect of Other General Anesthetics, Sequela

Locations

Country Name City State
Switzerland Dpt of Anesthesiology, University of Lausanne CHUV Lausanne VD

Sponsors (2)

Lead Sponsor Collaborator
University of Lausanne Hospitals Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Computerized classification of difficult intubation automatic classification by artificial intelligence into 3 classes of intubation difficulty 1 day