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NCT Number: NCT07114549

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

Location status: Recruiting

Location contact

Christian Zöllner, MD

PRINCIPAL_INVESTIGATOR

Martin Petzoldt, MD

CONTACT

[email protected]

+49 152 2281 5932

Martin Petzoldt, MD

PRINCIPAL_INVESTIGATOR

Viktor A. Wünsch, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

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

Secondary outcomes

  1. Impossible facemask ventilation

    Time frame: 1 hour

    Impossible facemask ventilation observed after induction of anesthesia (absence of end-tidal carbon dioxide measurement and lack of perceptible chest wall movement despite airway adjuvants and additional personnel after adequate neuromuscular blockade)

  2. Best capnograph achieved

    Time frame: 1 hour

    Best capnography waveform achieved during facemask ventilation (grade A-D)

  3. Optimization manoeuvers for facemask ventilation used

    Time frame: 1 hour

    Optimization manouvers such as oral airway, jaw-thrust or two-handed grip used as documented facemask ventilation

  4. Leak fraction

    Time frame: 1 hour

    Leak fraction (leak volume/ tidal volume) during facemask ventilation

  5. Tidal volume

    Time frame: 1 hour

    Tidal volume during facemask ventilation (ml)

  6. Senior anaesthetist taking over

    Time frame: 1 hour

    Senior anaesthetist taking over facemask ventilation as documented after facemask ventilation

  7. Timing of neuromuscular blocking agent

    Time frame: 1 hour

    Observed during airway management (before/ after facemask ventilation)

  8. Ventilation mode during facemask ventilation

    Time frame: 1 hour

    Manual or controlled ventilation applied by the airway operator

  9. Change of ventilation mode during mask ventilation

    Time frame: 1 hour

    Observed during mask ventilation (to manual or controlled)

  10. Difficult tracheal intubation

    Time frame: 1 hour

    Multiple tracheal intubation attempts documented after tracheal intubation

  11. Difficult laryngoscopy

    Time frame: 1 hour

    Observed difficult laryngoscopy with restricted glottis view documented after tracheal intubation

  12. First attempt success

    Time frame: 1 hour

    Successful tracheal intubation with only one attempt observed during tracheal intubation

  13. Number of intubation attempts

    Time frame: 1 hour

    Observed during airway management

  14. Number of laryngoscopy attempts

    Time frame: 1 hour

    Observed during airway management

  15. Glottic view during laryngoscopy

    Time frame: 1 hour

    Grading of the best view obtained using landmarks (6-stages)

  16. Percentage of glottis opening

    Time frame: 1 hour

    Grading of the best view obtained during laryngoscopy (%)

  17. VIDiAC Score

    Time frame: 1 hour

    Classification of difficult (video-)laryngoscopic intubation (total score -1 to 5)

  18. Failed primary intubation technique

    Time frame: 1 hour

    First-choice tracheal intubation technique unsuccessful

  19. Lowest peripheral oxygen saturation

    Time frame: 1 hour

    Observed during airway management (%)

  20. Drop of peripheral oxygen saturation during facemask ventilation

    Time frame: 1 hour

    Observed during facemask ventilation (%)

  21. 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

  22. Post-intubation recommendation for an intubation method

    Time frame: 1 hour

    Recommendation issued by the airway operator after airway management for either awake tracheal intubation, camera-assisted intubation, direct laryngoscopy or other techniques

  23. Anaesthesia alert card issued

    Time frame: 1 hour

    Anaesthesia alert card issued by the airway operator after airway management

    Anaesthesia alert card issued by the airway operator after airwaymanagement

  24. Difficult tracheal intubation alert

    Time frame: 1 hour

    "Difficult tracheal intubation alert" issued by the airway operator after tracheal intubation in health records

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Petzoldt, MD

CONTACT

[email protected]

+49 152 2281 5932

Viktor A Wünsch, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 21, 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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