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

NCT07275502 · tracked via the Priya Life Science Germany tracker

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Phase

Observational

Started

2022-11-07

Last updated

2025-12-10

Condition(s) studied

Airway ManagementMask VentilationNoninvasive Ventilation

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07275502 on ClinicalTrials.gov ↗ ← All trials in Germany