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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07275502

Enrollment

423

Registered

2025-12-10

Start date

2022-11-07

Completion date

2025-11-30

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management, Mask Ventilation, Noninvasive Ventilation

Keywords

Difficult facemask ventilation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Impossible facemask ventilation	1 hour	Observed impossible facemask ventilation after induction of anaesthesia (y/n)
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

Countries

Germany

Outcome results