An interventional study of SafeLM Video Laryngeal Mask and LMA Classic in Airway Management, sponsored by Hanoi Medical University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Hanoi Medical University · Not applicable, Interventional, and Other
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.
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.
Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive airway management with the SafeLM video laryngeal mask during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.
Device: SafeLM Video Laryngeal Mask
Participants randomized to this arm will receive airway management with the LMA Classic during general anesthesia for elective fibroadenoma excision. The device will be inserted according to the standardized study protocol.
Device: LMA Classic
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.
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 surgery
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 insertion
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 attempts
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 insertion
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 insertion
Need for additional airway maneuvers
Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.
Time frame: During laryngeal mask insertion
Peak inspiratory pressure
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
End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation.
Time frame: At 5 and 30 minutes after successful laryngeal mask placement
Heart Rate
Heart rate will be recorded in beats per minute (bpm).
Time frame: At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
Blood staining on the laryngeal mask
Presence of visible blood staining on the laryngeal mask after removal.
Time frame: Immediately after device removal
Postoperative sore throat
Presence of patient-reported sore throat following general anesthesia.
Time frame: At 1 and 24 hours after surgery
Postoperative hoarseness
Presence of patient-reported hoarseness following general anesthesia.
Time frame: At 1 and 24 hours after surgery
Airway-related adverse events
Occurrence of airway-related adverse events, including laryngospasm and clinically evident regurgitation.
Time frame: From laryngeal mask insertion through postoperative observation, assessed up to 24 hours after surgery
Arterial Pressure
Arterial pressure will be recorded in mmHg.
Time frame: At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Hanoi Medical University