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Recruiting NCT07114549

External Validation of the MASCAN Score for the Classification of Difficult Mask Ventilation

Observational Airway Management General Anesthesia Mask Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Airway Management, General Anesthesia, Mask Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The MASCAN Score is a prospectively developed objective classification for difficult facemask ventilation. This prospective observational study aims to externally validate the MASCAN score in patients undergoing general anaesthesia for surgical procedures and to determine the influence of different approaches and techniques, such as the timing of neuromuscular blocking agents and manual versus controlled facemask ventilation. A secondary aim is to determine the diagnostic value of visual assessments of the capnography curve. Another secondary aim of the study is to compare the assessment of the first attempt success during tracheal intubation between the airway operator and an independent observer.

Primary outcome measures

  • Difficult facemask ventilation [Time frame: 1 hour]
Secondary outcome measures (12)
  • Impossible facemask ventilation [Time frame: 1 hour]
  • Best capnograph achieved [Time frame: 1 hour]
  • Optimization manoeuvers for facemask ventilation used [Time frame: 1 hour]
  • Leak fraction [Time frame: 1 hour]
  • Tidal volume [Time frame: 1 hour]
  • Senior anaesthetist taking over [Time frame: 1 hour]
  • Timing of neuromuscular blocking agent [Time frame: 1 hour]
  • Ventilation mode during facemask ventilation [Time frame: 1 hour]
  • Change of ventilation mode during mask ventilation [Time frame: 1 hour]
  • Difficult tracheal intubation [Time frame: 1 hour]
  • Difficult laryngoscopy [Time frame: 1 hour]
  • First attempt success [Time frame: 1 hour]

Eligibility criteria

Inclusion criteria

  • Patients who are scheduled for surgery with general anesthesia and require facemask ventilation and tracheal intubation after induction of anesthesia
  • Patients aged 18 years or older
  • Provided informed consent

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Required rapid sequence induction or other contraindications for facemask ventilation
  • Planned awake tracheal intubation
  • No consent given

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Medical Center Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT07114549 · 2025-101524-BO-ff

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗