SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
ConditionAirway Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHanoi Medical University
About this trial
This randomized controlled trial compares the airway management performance of the SafeLM video laryngeal mask with the LMA Classic in adult patients undergoing elective fibroadenoma excision under general anesthesia. Participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic. The primary outcome is oropharyngeal leak pressure. Secondary outcomes include insertion performance, ventilation parameters, hemodynamic responses, and airway-related adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 years or older.
Scheduled for elective excision of benign breast fibroadenoma under general anesthesia.
Planned airway management with a laryngeal mask airway.
American Society of Anesthesiologists (ASA) physical status I-II.
Disqualifiers
Increased risk of pulmonary aspiration, including inadequate preoperative fasting, full stomach, or gastrointestinal obstruction.
Known or suspected difficult airway or other airway characteristics for which random allocation between the two study devices is considered clinically inappropriate.
Upper airway pathology or anatomical abnormality that may interfere with laryngeal mask placement.
Clinical or surgical indication requiring tracheal intubation rather than a laryngeal mask airway.
Trial design
Design model
Parallel
Treatments tested in this trial
SafeLM Video Laryngeal Mask
DeviceThe SafeLM is a video-assisted supraglottic airway device that allows visualization of the laryngeal structures during insertion and positioning. It will be used for airway management during general anesthesia according to the standardized study protocol.
LMA Classic
DeviceThe LMA Classic is a conventional supraglottic airway device without video guidance. It will be used for airway management during general anesthesia according to the standardized study protocol.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: SafeLM Video Laryngeal MaskExperimental treatment 1 intervention
Group B: LMA ClassicActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oropharyngeal Leak Pressure (OLP)
Oropharyngeal leak pressure will be measured after successful placement of the assigned laryngeal mask and establishment of effective ventilation. OLP will be recorded in cmH2O as the airway pressure at which an audible oropharyngeal leak is detected during a standardized leak test.
Time frame
Immediately after successful laryngeal mask placement, before the start of surgerySecondary outcomes
1
First-attempt insertion success
Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask.
Time frame
During initial laryngeal mask insertion2
Overall insertion success
Proportion of participants in whom effective ventilation is achieved with the assigned laryngeal mask within the maximum number of insertion attempts permitted by the study protocol.
Time frame
During laryngeal mask insertion, up to 3 attempts3
Laryngeal mask insertion time
Time in seconds from introduction of the assigned laryngeal mask into the mouth until establishment of effective ventilation.
Time frame
During laryngeal mask insertion4
Number of insertion attempts
Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask.
Time frame
During laryngeal mask insertionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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