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Active, Not Recruiting

NCT Number: NCT07275502

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difficult facemask ventilation

    Time frame: 1 hour

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

Secondary outcomes

  1. Impossible facemask ventilation

    Time frame: 1 hour

    Observed impossible facemask ventilation after induction of anaesthesia (y/n)

  2. Airway-related adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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