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

NCT07275502 | Active Not Recruiting

• 1 other identifier: 2025-300636-WF
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management; Mask Ventilation; Noninvasive Ventilation

Keywords

Difficult facemask ventilation

Outcome Measures

Primary Outcomes (1)

• Difficult facemask ventilation

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

  1 hour

Secondary Outcomes (2)

• Impossible facemask ventilation

  1 hour

• Airway-related adverse events

  1 hour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding woman
• Rapid sequence induction or other contraindications for facemask ventilation
• Planned awake tracheal intubation

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Study Officials

• Martin Petzoldt, MD

  University Medical Centre Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: November 7, 2022
• Primary Completion: May 15, 2023
• Study Completion: November 30, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

DE (1)