MASCAN: Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05411406

Collaborator

Institute of Medical Technology and Intelligent Systems at Hamburg University of Technology (Other)

420

Enrollment

Location

Anticipated Duration (Months)

52.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mask Ventilation General Anesthesia

Study Design

Study Type:

Observational

Anticipated Enrollment :

420 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Proof-of-principle Study for the Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Study cohort Patients undergoing ENT or OMS surgery with general anesthesia with facemask ventilation and tracheal intubation (observational)

Outcome Measures

Primary Outcome Measures

Difficult facemask ventilation [1 hour]
Observed difficult facemask ventilation after induction of anesthesia

Secondary Outcome Measures

Difficult tracheal intubation [1 hour]
Observed difficult intubation after induction of anesthesia
Difficult laryngoscopy [1 hour]
Observed difficult laryngoscopy after induction of anesthesia
Number of attempts [1 hour]
Observed during tracheal intubation
Failed direct laryngoscopy [1 hour]
Observed during airwaymanagement
Cormack Lehane grade [1 hour]
Grading of the best view obtained during laryngoscopy (I-IV)
Difficult mask ventilation alert [1 hour]
Noted by the responsible anaesthesiologist after airway management
Difficult intubation alert [1 hour]
Noted by the responsible anaesthesiologist after airway management
Intubation time [1 hour]
Recorded during airwaymanagement
Time to sufficient mask ventilation [1 hour]
Recorded during airwaymanagement
Classification of intubation difficulty [1 hour]
VIDIAC score rating between -1 and 5 points
Percentage of glottis opening (POGO) [1 hour]
Grading of the best view obtained during laryngoscopy (%)
Impossible facemask ventilation [1 hour]
Observed impossible facemask ventilation after induction of anesthesia
Successful first attempt intubation [1 hour]
Observed during airway management
Airway-related adverse events [1 hour]
Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia
Post-intubation recommendation for an intubation method [1 hour]
Recommendation of the responsible anaesthesiologist after airwaymanagement
Minimal peripheral oxygen saturation (SpO2) [1 hour]
Observed after induction of anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf
Institute of Medical Technology and Intelligent Systems at Hamburg University of Technology

Investigators

Principal Investigator: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT05411406

Other Study ID Numbers:

2022-100811-BO-ff

First Posted:

Jun 9, 2022

Last Update Posted:

Jun 9, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

Risk prediction

Airway management

Study Results

No Results Posted as of Jun 9, 2022