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

Recruiting

• Conditions: Airway Management; General Anesthesia; Mask Ventilation

• Registration Number: NCT07114549
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-27
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-03
• Study Start: 2025-08-08
• Study First Posted: 2025-08-11
• Last Update Submitted: 2025-08-17
• Last Update Posted: 2025-08-21
• Primary Completion: 2025-12
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 926

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difficult facemask ventilation	1 hour	Alert documented in patients health records by the airway operator following facemask ventilation

Secondary Outcome Measures

Name	Time	Method
Impossible facemask ventilation	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)
Best capnograph achieved	1 hour	Best capnography waveform achieved during facemask ventilation (grade A-D)
Optimization manoeuvers for facemask ventilation used	1 hour	Optimization manouvers such as oral airway, jaw-thrust or two-handed grip used as documented facemask ventilation
Leak fraction	1 hour	Leak fraction (leak volume/ tidal volume) during facemask ventilation
Tidal volume	1 hour	Tidal volume during facemask ventilation (ml)
Senior anaesthetist taking over	1 hour	Senior anaesthetist taking over facemask ventilation as documented after facemask ventilation
Timing of neuromuscular blocking agent	1 hour	Observed during airway management (before/ after facemask ventilation)
Ventilation mode during facemask ventilation	1 hour	Manual or controlled ventilation applied by the airway operator
Change of ventilation mode during mask ventilation	1 hour	Observed during mask ventilation (to manual or controlled)
Difficult tracheal intubation	1 hour	Multiple tracheal intubation attempts documented after tracheal intubation
Difficult laryngoscopy	1 hour	Observed difficult laryngoscopy with restricted glottis view documented after tracheal intubation
First attempt success	1 hour	Successful tracheal intubation with only one attempt observed during tracheal intubation
Number of intubation attempts	1 hour	Observed during airway management
Number of laryngoscopy attempts	1 hour	Observed during airway management
Glottic view during laryngoscopy	1 hour	Grading of the best view obtained using landmarks (6-stages)
Percentage of glottis opening	1 hour	Grading of the best view obtained during laryngoscopy (%)
VIDiAC Score	1 hour	Classification of difficult (video-)laryngoscopic intubation (total score -1 to 5)
Failed primary intubation technique	1 hour	First-choice tracheal intubation technique unsuccessful
Lowest peripheral oxygen saturation	1 hour	Observed during airway management (%)
Drop of peripheral oxygen saturation during facemask ventilation	1 hour	Observed during facemask ventilation (%)
Airway-related adverse events	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
Post-intubation recommendation for an intubation method	1 hour	Recommendation issued by the airway operator after airway management for either awake tracheal intubation, camera-assisted intubation, direct laryngoscopy or other techniques
Anaesthesia alert card issued	1 hour	Anaesthesia alert card issued by the airway operator after airway management; Anaesthesia alert card issued by the airway operator after airwaymanagement
Difficult tracheal intubation alert	1 hour	"Difficult tracheal intubation alert" issued by the airway operator after tracheal intubation in health records

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany