Prospective Development and Validation of an Objective Classification for Difficult Facemask Vent… (NCT07275502) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Score
Germany423 participantsStarted 2022-11-07
Plain-language summary
Difficult facemask ventilation remains poorly classified. Existing definitions rely on expert opinion and subjective rating of surrogates. This lack of standardization has led to highly variable reported incidences and inconsistencies in clinical practice and research.
This secondary analysis of the prospective observational MASCAN study aims to develop and validate a data-driven objective classification system for difficult facemask ventilation and to determine its diagnostic performance and calibration. Facemask ventilation was facilitated after anaesthesia induction in all patients. An independent observer systematically assessed potential indicators for difficult facemask ventilation that serve as candidate predictor variables for the fitting of a diagnostic multivariable logistic regression model and simplified score to classify difficult facemask ventilation. Cross-validated LASSO regression will be used for variable selection. The area under the receiver operating characteristic curve (AUROC) and calibration curves will be used to quantify the diagnostic performance and calibration, and optimal decision thresholds will be defined.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduling for ENT or OMS surgery in general anaesthesia, who require facemask ventilation and tracheal intubation after induction of anesthesia
* Patients aged at least 18 years
* Ability to understand the patient information and to personally sign and date the informed consent to participate in the study
* The patient is co-operative and available for the entire study
* Provided informed consent/patient representative
Exclusion Criteria:
* Pregnant or breastfeeding woman
* Rapid sequence induction or other contraindications for facemask ventilation
* Planned awake tracheal intubation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.