Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Score

Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Score - Secondary Analysis of the Prospective Observational MASCAN Study

Difficult facemask ventilation remains poorly classified. Existing definitions rely on expert opinion and subjective rating of surrogates. This lack of standardization has led to highly variable reported incidences and inconsistencies in clinical practice and research.

This secondary analysis of the prospective observational MASCAN study aims to develop and validate a data-driven objective classification system for difficult facemask ventilation and to determine its diagnostic performance and calibration. Facemask ventilation was facilitated after anaesthesia induction in all patients. An independent observer systematically assessed potential indicators for difficult facemask ventilation that serve as candidate predictor variables for the fitting of a diagnostic multivariable logistic regression model and simplified score to classify difficult facemask ventilation. Cross-validated LASSO regression will be used for variable selection. The area under the receiver operating characteristic curve (AUROC) and calibration curves will be used to quantify the diagnostic performance and calibration, and optimal decision thresholds will be defined.

Study Overview

• Status: Active, not recruiting
• Conditions: Airway Management; Noninvasive Ventilation; Mask Ventilation

• Study Type: Observational
• Enrollment (Actual): 423

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult facemask ventilation	Alert documented in patients' health records by the airway operator following facemask ventilation (y/n)	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway-related adverse events	Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia	1 hour
Impossible facemask ventilation	Observed impossible facemask ventilation after induction of anaesthesia (y/n)	1 hour

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Martin Petzoldt, MD, University Medical Centre Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): May 15, 2023
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Difficult facemask ventilation
• Other Study ID Numbers: 2025-300636-WF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No