Airway ManagementNCT07114549
External Validation of the MASCAN Score for the Classification of Difficult Mask Ventilation
An observational study of Airway Management and General Anesthesia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management, General Anesthesia, Mask Ventilation
- How many people
- 926 participants
- Where
- 1 siteGermany
- Study dates
- 8 Aug 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding woman
- Required rapid sequence induction or other contraindications for facemask ventilation
- Planned awake tracheal intubation
- No consent given
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Viktor A Wünsch, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Martin Petzoldt, MD, +49 152 2281 5932, m.petzoldt@uke.de
Martin Petzoldt, MD
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing general anaesthesia with facemask ventilation | Measurement of primary and secondary outcome parameters during induction of anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult facemask ventilation
Alert documented in patients health records by the airway operator following facemask ventilation
Measured: 1 hour
Secondary outcomes (24)
Impossible facemask ventilation
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)
Measured: 1 hour
Best capnograph achieved
Best capnography waveform achieved during facemask ventilation (grade A-D)
Measured: 1 hour
Optimization manoeuvers for facemask ventilation used
Optimization manouvers such as oral airway, jaw-thrust or two-handed grip used as documented facemask ventilation
Measured: 1 hour
Leak fraction
Leak fraction (leak volume/ tidal volume) during facemask ventilation
Measured: 1 hour
Tidal volume
Tidal volume during facemask ventilation (ml)
Measured: 1 hour
Senior anaesthetist taking over
Senior anaesthetist taking over facemask ventilation as documented after facemask ventilation
Measured: 1 hour
Timing of neuromuscular blocking agent
Observed during airway management (before/ after facemask ventilation)
Measured: 1 hour
Ventilation mode during facemask ventilation
Manual or controlled ventilation applied by the airway operator
Measured: 1 hour
Change of ventilation mode during mask ventilation
Observed during mask ventilation (to manual or controlled)
Measured: 1 hour
Difficult tracheal intubation
Multiple tracheal intubation attempts documented after tracheal intubation
Measured: 1 hour
Difficult laryngoscopy
Observed difficult laryngoscopy with restricted glottis view documented after tracheal intubation
Measured: 1 hour
First attempt success
Successful tracheal intubation with only one attempt observed during tracheal intubation
Measured: 1 hour
Number of intubation attempts
Observed during airway management
Measured: 1 hour
Number of laryngoscopy attempts
Observed during airway management
Measured: 1 hour
Glottic view during laryngoscopy
Grading of the best view obtained using landmarks (6-stages)
Measured: 1 hour
Percentage of glottis opening
Grading of the best view obtained during laryngoscopy (%)
Measured: 1 hour
VIDiAC Score
Classification of difficult (video-)laryngoscopic intubation (total score -1 to 5)
Measured: 1 hour
Failed primary intubation technique
First-choice tracheal intubation technique unsuccessful
Measured: 1 hour
Lowest peripheral oxygen saturation
Observed during airway management (%)
Measured: 1 hour
Drop of peripheral oxygen saturation during facemask ventilation
Observed during facemask ventilation (%)
Measured: 1 hour
Airway-related adverse events
Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia
Measured: 1 hour
Post-intubation recommendation for an intubation method
Recommendation issued by the airway operator after airway management for either awake tracheal intubation, camera-assisted intubation, direct laryngoscopy or other techniques
Measured: 1 hour
Anaesthesia alert card issued
Anaesthesia alert card issued by the airway operator after airway management
Anaesthesia alert card issued by the airway operator after airwaymanagement
Measured: 1 hour
Difficult tracheal intubation alert
"Difficult tracheal intubation alert" issued by the airway operator after tracheal intubation in health records
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start8 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 926 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114549
- Sponsor's protocol ID
- 2025-101524-BO-ff
- Other IDs
- 2025
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the MASCAN Score for the Classification of Difficult Mask Ventilation
- ClinicalTrials.gov ID
- NCT07114549
- Acronym / sponsor ID
- 2025-101524-BO-ff
- Conditions
- Airway Management, General Anesthesia, Mask Ventilation
- Keywords
- Airway management, Mask ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 926 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing general anaesthesia with facemask ventilation | – | –Measurement of primary and secondary outcome parameters during induction of anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding woman
- Required rapid sequence induction or other contraindications for facemask ventilation
- Planned awake tracheal intubation
- No consent given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difficult facemask ventilation
Time frame: 1 hour
Alert documented in patients health records by the airway operator following facemask ventilation
24 secondary outcomes
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
Number of intubation attempts
Time frame: 1 hour
Number of laryngoscopy attempts
Time frame: 1 hour
Glottic view during laryngoscopy
Time frame: 1 hour
Percentage of glottis opening
Time frame: 1 hour
VIDiAC Score
Time frame: 1 hour
Failed primary intubation technique
Time frame: 1 hour
Lowest peripheral oxygen saturation
Time frame: 1 hour
Drop of peripheral oxygen saturation during facemask ventilation
Time frame: 1 hour
Airway-related adverse events
Time frame: 1 hour
Post-intubation recommendation for an intubation method
Time frame: 1 hour
Anaesthesia alert card issued
Time frame: 1 hour
Difficult tracheal intubation alert
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viktor A Wünsch, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management and General Anesthesia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Petzoldt, MD (+49 152 2281 5932, m.petzoldt@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult facemask ventilation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.