Airway ManagementNCT07835750
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
A study testing SafeLM Video Laryngeal Mask and LMA Classic in people with Airway Management, run by Hanoi Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Airway Management
- What is being tested?
- SafeLM Video Laryngeal Mask and LMA Classic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Both the SafeLM and LMA Classic are considered clinically appropriate for airway management.
- Provision of written informed consent.
Who cannot join
- 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.
- Contraindication or known allergy to medications used in the standardized anesthesia protocol.
- Inability to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Airway Control Effectiveness of the SafeLM Video Laryngeal Mask and the LMA Classic in Patients Undergoing General Anesthesia for Fibroadenoma Excision
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.
Read the detailed description
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.
- Conditions
- Airway Management
- Being tested
- SafeLM Video Laryngeal Mask, LMA Classic
- Keywords
- Laryngeal Mask Airway, Video Laryngeal Mask, SafeLM, LMA Classic, Oropharyngeal Leak Pressure, Supraglottic Airway Device, General Anesthesia, Fibroadenoma Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeLM Video Laryngeal MaskDevice
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.
LMA ClassicDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SafeLM Video Laryngeal Mask | Experimental | 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. Receives: Device: SafeLM Video Laryngeal Mask |
| LMA Classic | Active comparator | 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. Receives: Device: LMA Classic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after successful laryngeal mask placement, before the start of surgery
Secondary outcomes (13)
First-attempt insertion success
Proportion of participants in whom effective ventilation is achieved after the first insertion attempt of the assigned laryngeal mask.
Measured: 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.
Measured: 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.
Measured: During laryngeal mask insertion
Number of insertion attempts
Number of attempts required to achieve successful placement and effective ventilation with the assigned laryngeal mask.
Measured: During laryngeal mask insertion
Need for additional airway maneuvers
Proportion of participants requiring additional maneuvers to achieve satisfactory placement and ventilation.
Measured: During laryngeal mask insertion
Peak inspiratory pressure
Peak inspiratory airway pressure measured in cmH2O during mechanical ventilation.
Measured: At 5 and 30 minutes after successful laryngeal mask placement
End-tidal carbon dioxide
End-tidal carbon dioxide (EtCO2) measured during mechanical ventilation.
Measured: At 5 and 30 minutes after successful laryngeal mask placement
Heart Rate
Heart rate will be recorded in beats per minute (bpm).
Measured: 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.
Measured: Immediately after device removal
Postoperative sore throat
Presence of patient-reported sore throat following general anesthesia.
Measured: At 1 and 24 hours after surgery
Postoperative hoarseness
Presence of patient-reported hoarseness following general anesthesia.
Measured: At 1 and 24 hours after surgery
Airway-related adverse events
Occurrence of airway-related adverse events, including laryngospasm and clinically evident regurgitation.
Measured: From laryngeal mask insertion through postoperative observation, assessed up to 24 hours after surgery
Arterial Pressure
Arterial pressure will be recorded in mmHg.
Measured: At baseline, immediately after successful laryngeal mask placement, and at 5 and 30 minutes after placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835750
- Sponsor's protocol ID
- HMU-SAFELM-CLASSIC-2026-01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No