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

NCT07114549 | Recruiting

• 1 other identifier: 2025-101524-BO-ff
• Study Type: observational
• Target: 926
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Management; General Anesthesia; Mask Ventilation

Keywords

Airway management; Mask ventilation

Outcome Measures

Primary Outcomes (1)

• Difficult facemask ventilation

  Alert documented in patients health records by the airway operator following facemask ventilation

  1 hour

Secondary Outcomes (24)

• Impossible facemask ventilation

  1 hour

• Best capnograph achieved

  1 hour

• Optimization manoeuvers for facemask ventilation used

  1 hour

• Leak fraction

  1 hour

• Tidal volume

  1 hour

Study Arms (1)

Patients undergoing general anaesthesia with facemask ventilation

Measurement of primary and secondary outcome parameters during induction of anaesthesia

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 undergoing general anesthesia in a tertiary care hospital who require facemask ventilation and tracheal intubation after induction of anesthesia.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20251, Germany

RECRUITING

Central Study Contacts

Martin Petzoldt, MD

CONTACT

+49 152 2281 5932; m.petzoldt@uke.de

Viktor A Wünsch, MD

CONTACT

v.wuensch@uke.de

Study Design

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

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 11, 2025
• Study Start: August 8, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

DE (1)