Clinical trial NCT05411406: Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning
Official title: Proof-of-principle Study for the Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mask Ventilation
General Anesthesia
Keywords: Risk prediction
Airway management
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Institute of Medical Technology and Intelligent Systems at Hamburg University of Technology
First posted: 2022-06-09
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive sampling: Adult patients that undergo ENT or OMS surgery in a tertiary care hospital who require facemask ventilation and tracheal intubation after induction of anesthesia.

Brief summary: The aim of this study is to prove feasibility and assess the diagnostic performance of a machine learning algorithm that relies on data from 3D-face scans with predefined motion-sequences and scenes (MASCAN algorithm), together with patient-specific meta-data for the prediction of difficult mask ventilation. A secondary aim of the study is to verify whether voice and breathing scans improve the performance of the algorithm. From the clinical point of view, we believe that an automated assessment would be beneficial, as it preserves time and health-care resources while acting observer-independent, thus providing a rational, reproducible risk estimation.


Eligibility criteria: Inclusion Criteria:

* Patients scheduling for ENT or OMS surgery in general anaesthesia, who require facemask ventilation and tracheal intubation after induction of anesthesia
* Patients aged at least 18 years
* Ability to understand the patient information and to personally sign and date the informed consent to participate in the study
* The patient is co-operative and available for the entire study
* Provided informed consent/patient representative

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Rapid sequence induction or other contraindications for facemask ventilation
* Planned awake tracheal intubation

Primary outcomes:
measure: Difficult facemask ventilation
timeFrame: 1 hour
Secondary outcomes:
measure: Difficult tracheal intubation
timeFrame: 1 hour
measure: Difficult laryngoscopy
timeFrame: 1 hour
measure: Number of attempts
timeFrame: 1 hour
measure: Failed direct laryngoscopy
timeFrame: 1 hour
measure: Cormack Lehane grade
timeFrame: 1 hour
measure: Difficult mask ventilation alert
timeFrame: 1 hour
measure: Difficult intubation alert
timeFrame: 1 hour
measure: Intubation time
timeFrame: 1 hour
measure: Time to sufficient mask ventilation
timeFrame: 1 hour
measure: Classification of intubation difficulty
timeFrame: 1 hour
measure: Percentage of glottis opening (POGO)
timeFrame: 1 hour
measure: Impossible facemask ventilation
timeFrame: 1 hour
measure: Successful first attempt intubation
timeFrame: 1 hour
measure: Airway-related adverse events
timeFrame: 1 hour
measure: Post-intubation recommendation for an intubation method
timeFrame: 1 hour
measure: Minimal peripheral oxygen saturation (SpO2)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: PRINCIPAL_INVESTIGATOR
References: