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

NCT ID: NCT05411406

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mask Ventilation General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study cohort

Patients undergoing ENT or OMS surgery with general anesthesia with facemask ventilation and tracheal intubation (observational)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institute of Medical Technology and Intelligent Systems at Hamburg University of Technology

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Petzoldt, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-100811-BO-ff

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Post Extubation Dysphagia
NCT01849679 COMPLETED