NCT Number: NCT07835750
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
The SafeLM is a video-assisted laryngeal mask that allows visualization during placement, whereas the LMA Classic is a conventional supraglottic airway device. This study is designed to compare the clinical performance of these two devices under standardized conditions.
Adult patients scheduled for elective fibroadenoma excision under general anesthesia will be screened for eligibility. Only patients for whom both devices are considered clinically appropriate will be enrolled, thereby avoiding randomization when patient characteristics indicate a preference for a particular airway management technique. Eligible participants will be randomly assigned to airway management with either the SafeLM or the LMA Classic.
After standardized induction of general anesthesia, the assigned laryngeal mask will be inserted according to the study protocol. The primary outcome is oropharyngeal leak pressure after successful placement. Device insertion characteristics, ventilation parameters, hemodynamic responses, and airway-related adverse events will also be evaluated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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.
The 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.
Time frame: Immediately after successful laryngeal mask placement, before the start of surgery
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: During initial laryngeal mask insertion
Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask.
Time frame: During laryngeal mask insertion, up to 3 attempts
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
Time in seconds from introduction of the assigned laryngeal mask into the mouth until establishment of effective ventilation.
Time frame: During laryngeal mask insertion
Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask.
Time frame: During laryngeal mask insertion
Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.
Time frame: At 5 and 30 minutes after successful laryngeal mask placement
Peak inspiratory airway pressure measured in cmH2O during mechanical ventilation.
Time frame: At 5 and 30 minutes after successful laryngeal mask placement
End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation.
Time frame: At baseline, immediately after insertion, and 5 and 30 minutes after successful placement
Heart rate and mean arterial pressure recorded to assess hemodynamic changes associated with laryngeal mask insertion.
Time frame: Immediately after device removal
Presence of visible blood staining on the laryngeal mask after removal.
Time frame: At 1 and 24 hours after surgery
Presence of patient-reported sore throat following general anesthesia.
Time frame: At 1 and 24 hours after surgery
Presence of patient-reported hoarseness following general anesthesia.
Time frame: From laryngeal mask insertion through post-anesthesia care unit discharge
Occurrence of airway-related adverse events, including laryngospasm and clinically evident regurgitation.
Contact information is provided by the study sponsor or research team.
Hanoi Medical University
Other
Comparison of Airway Control Effectiveness of the SafeLM Video Laryngeal Mask and the LMA Classic in Patients Undergoing General Anesthesia for Fibroadenoma Excision
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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